Creation Date : 11/09/2021

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
TÜV NORD CERT GmbH 0044
*MD 1300 - Monitoring devices EC declaration of Annex II
Langemarckstraße 20
45141 Essen - *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
Germany physiological parameters assurance system)
Annex VI
- *MD 1302 - Monitoring devices of vital physiological EC declaration of
parameters conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo
therapy EC declaration of
conformity (product quality
- *MD 1401 - Devices utilising ionizing radiation
assurance)
- *MD 1402 - Devices utilising non-ionizing radiation
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
- *MD 0101 - Non-active devices for anaesthesia, Product quality assurance
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V

- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0201 - Non-active cardiovascular implants system Annex V
- *MD 0202 - Non-active orthopaedic implants Production quality Annex VI
assurance
- *MD 0203 - Non-active functional implants
Product quality assurance
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
- *MD 1102 - Respiratory devices, devices including EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

hyperbaric chambers for oxygen therapy, inhalation quality assurance)

anaesthesia EC declaration of
- *MD 1103 - Devices for stimulation or inhibition conformity (product quality
- *MD 1104 - Active surgical devices assurance)

- *MD 1105 - Active ophthalmologic devices

- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal without medical devices according
origin, including Regulation 722/2012 (Directive to Commission Regulation (EU) No
2003/32/EC up to 28.08.2013) 722/2012
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas
sterilisation (EOG), moist heat
sterilisation, radiation sterilisation
(gamma, x-ray, electron beam),
low temperature steam and
formaldehyde sterilisation, thermic
sterilisation with dry heat
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
National Standards Authority of Ireland (NSAI) 0050
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
1 Swift Square, Northwood, Santry
Dublin 9 medical devices conformity (full quality Annex V
Ireland - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0103 - Non-active orthopaedic and rehabilitation EC declaration of

devices conformity (product quality
assurance)
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0109 - Non-active devices for in vitro fertilisation

(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1107 - Active devices for disinfection and

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
- *MD 1106 - Active dental devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
IMQ ISTITUTO ITALIANO DEL MARCHIO DI 0051
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
QUALITÀ S.P.A.
Via Quintiliano, 43 medical devices conformity (full quality Annex V
20138 - MILANO - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
Italy
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II exclusion medical devices class III
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II exclusion medical devices class III
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II exclusion medical devices class III
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II exclusion medical devices class III
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II exclusion medical devices class III
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II exclusion medical devices class III
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II exclusion medical devices class III
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV

infusion and haemopheresis EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV
hyperbaric chambers for oxygen therapy, inhalation EC declaration of Annex II
anaesthesia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1104 - Active surgical devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1105 - Active ophthalmologic devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1106 - Active dental devices EC verification Annex IV

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1107 - Active devices for disinfection and EC verification Annex IV
sterilisation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III
- *MD 1201 - Imaging devices utilising ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex V

EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV
parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1401 - Devices utilising ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II
conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1403 - Devices for hyperthermia / hypothermia EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1404 - Devices for (extracorporal) shock-wave EC declaration of Annex II
therapy (lithotripsy) conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam
sterilisation, moist heat
sterilisation, radiation sterilisation
(gamma, x-ray, electron beam)
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
MTIC InterCert S.r.l. 0068
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III Medical Devices
Sede Legale: Via G.Leopardi, 14 - Sede
Operativa: Via Moscova, 11 - *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
20123 - Milano (MI) - 20017 - Rho (MI) radiation assurance system)
Annex VI
Italy
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III Medical Devices
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III Excluding class III Medical Devices
therapy EC verification Annex IV
- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III Medical Devices
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III Medical Devices
- *MD 1107 - Active devices for disinfection and EC declaration of Annex II
sterilisation conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III Medical Devices
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III Medical Devices
- *MD 1102 - Respiratory devices, devices including EC declaration of Annex II and hyperbaric chambers
hyperbaric chambers for oxygen therapy, inhalation conformity (full quality Annex V
anaesthesia assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC verification Annex IV Excluding class III Medical Devices
- *MD 1103 - Devices for stimulation or inhibition EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III Medical Devices
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III Medical Devices
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III Medical Devices
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III Medical Devices
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III Medical Devices
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7006 - Medical devices in sterile condition
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
TÜV SÜD Product Service GmbH 0123
*MD 1300 - Monitoring devices Full quality assurance Annex II
Zertifizierstellen
Ridlerstraße 65 - *MD 1301 - Monitoring devices of non-vital system Annex III
80339 MÜNCHEN physiological parameters EC type-examination Annex IV
Germany
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex V
parameters Production quality Annex VI
*MD 1400 - Devices for radiation therapy and thermo assurance
therapy Product quality assurance
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable

medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
- *MD 0104 - Non-active medical devices with Product quality assurance
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex III
- *MD 0109 - Non-active devices for in vitro fertilisation EC type-examination Annex IV
(IVF) and assisted reproductive technologies (ART) EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0110 - Non-active medical devices for ingestion EC declaration of Annex II
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0201 - Non-active cardiovascular implants system Annex III
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
- *MD 0203 - Non-active functional implants Production quality Annex VI
assurance
- *MD 0204 - Non-active soft tissue implants
Product quality assurance
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0402 - Dental materials

- *MD 0403 - Dental implants
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex III
infusion and haemopheresis EC type-examination Annex IV
- *MD 1102 - Respiratory devices, devices including EC verification Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
- *MD 1103 - Devices for stimulation or inhibition Product quality assurance
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1110 - Active devices for in vitro fertilisation EC verification Annex IV
(IVF) and assisted reproductive therapy (ART) EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex III
radiation EC type-examination Annex IV
- *MD 1201 - Imaging devices utilising ionizing EC verification Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

peroxide, thermic sterilisation with

dry heat, sterilisation with liquid
sterilants
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
DEKRA Certification GmbH 0124
*MD 0200 - Non-active implants Full quality assurance Annex II
Handwerkstraße 15
70565 STUTTGART - *MD 0201 - Non-active cardiovascular implants system Annex V
Germany Production quality
- *MD 0202 - Non-active orthopaedic implants Annex VI
assurance
- *MD 0203 - Non-active functional implants
Product quality assurance
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

infusion and haemopheresis assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
- *MD 1104 - Active surgical devices Annex VI
EC declaration of
- *MD 1105 - Active ophthalmologic devices
conformity (production
- *MD 1106 - Active dental devices
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V
sterilisation Production quality Annex VI
- *MD 1108 - Active rehabilitation devices and active assurance
prostheses Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
conformity (full quality
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1109 - Active devices for patient positioning and assurance system) Annex V
transport EC declaration of Annex VI
- *MD 1111 - Software conformity (production
- *MD 1112 - Medical gas supply systems and parts quality assurance)
thereof EC declaration of
*MD 1200 - Devices for imaging conformity (product quality
assurance)
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
- *MD 1403 - Devices for hyperthermia / hypothermia EC declaration of
conformity (production
- *MD 1404 - Devices for (extracorporal) shock-wave
quality assurance)
therapy (lithotripsy)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
- *MD 0102 - Non-active devices for injection, infusion, Product quality assurance
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0109 - Non-active devices for in vitro fertilisation Product quality assurance
(IVF) and assisted reproductive technologies (ART)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
TÜV Rheinland LGA Products GmbH 0197
*MD 1300 - Monitoring devices Full quality assurance Annex II
Tillystraße 2
90431 Nürnberg - *MD 1301 - Monitoring devices of non-vital system Annex III
Germany physiological parameters EC type-examination Annex IV

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1302 - Monitoring devices of vital physiological system Annex III
parameters EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex III
- *MD 1401 - Devices utilising ionizing radiation EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex III
- *MD 1402 - Devices utilising non-ionizing radiation EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy system Annex III

- *MD 1403 - Devices for hyperthermia / hypothermia EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex III
- *MD 1404 - Devices for (extracorporal) shock-wave EC type-examination Annex IV
therapy (lithotripsy) EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0201 - Non-active cardiovascular implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II excluding implants for full
- *MD 0202 - Non-active orthopaedic implants system Annex V replacement of the hip, shoulder,
Production quality knee
Annex VI
assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0200 - Non-active implants Full quality assurance Annex II

- *MD 0203 - Non-active functional implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex III
transport EC type-examination Annex IV

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex III
infusion and haemopheresis EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding hyperbaric therapy
- *MD 1102 - Respiratory devices, devices including system Annex III chambers
hyperbaric chambers for oxygen therapy, inhalation EC type-examination Annex IV
anaesthesia EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding devices for stimulating
- *MD 1103 - Devices for stimulation or inhibition system Annex III the brain
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1104 - Active surgical devices system Annex III

EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1105 - Active ophthalmologic devices system Annex III
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex III
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex III
sterilisation EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1108 - Active rehabilitation devices and active system Annex III
prostheses EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1110 - Active devices for in vitro fertilisation system Annex III
(IVF) and assisted reproductive therapy (ART) EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1111 - Software system Annex III
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0105 - Non-active ophthalmologic devices assurance system) Annex V

EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0109 - Non-active devices for in vitro fertilisation Production quality Annex V
(IVF) and assisted reproductive technologies (ART) assurance Annex VI
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex III
radiation EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex III
radiation EC type-examination Annex IV

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive for active medical devices only
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
electron beam), low temperature
steam and formaldehyde
sterilisation, sterilisation with
hydrogen peroxide, thermic
sterilisation with dry heat,
sterilisation by liquid chemical
sterilants
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

/utilising software /controlled by software

DQS Medizinprodukte GmbH 0297
*MD 1200 - Devices for imaging Full quality assurance Annex II
August-Schanz-Straße 21
60433 FRANKFURT AM MAIN - *MD 1201 - Imaging devices utilising ionizing system Annex V
Germany radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1301 - Monitoring devices of non-vital system Annex V
physiological parameters Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1302 - Monitoring devices of vital physiological system Annex V
parameters Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy system Annex V

- *MD 1402 - Devices utilising non-ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave Production quality Annex VI
therapy (lithotripsy) assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality
transfusion and dialysis assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality
emergency and intensive care assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality
devices assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality
measuring function assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0105 - Non-active ophthalmologic devices Production quality

assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality
assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality
disinfecting, cleaning, rinsing assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II vascular implants only
- *MD 0201 - Non-active cardiovascular implants system Annex V
Production quality
assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Production quality
assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0203 - Non-active functional implants system Annex V
Production quality
assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0204 - Non-active soft tissue implants system Annex V
Production quality
assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality
assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex V
Production quality
assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality
assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality
assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0402 - Dental materials system Annex V

Production quality
assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality
assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1105 - Active ophthalmologic devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V
sterilisation Production quality Annex VI
assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1108 - Active rehabilitation devices and active system Annex V
prostheses Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex V
transport Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1111 - Software system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex V
infusion and haemopheresis Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1103 - Devices for stimulation or inhibition system Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Production quality Annex VI

assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

dry heat
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
AGENCIA ESPAÑOLA DE MEDICAMENTOS 0318
*MD 1200 - Devices for imaging EC declaration of Annex II Limitated to X-ray medical devices
Y PRODUCTOS SANITARIOS
Campezo 1. Edificio 8 - *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V and gamma cameras
28022 MADRID radiation assurance system)
Annex VI
Spain
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
conformity (full quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1302 - Monitoring devices of vital physiological assurance system) Annex V

parameters EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Limitated to microwave and
therapy conformity (full quality Annex V magnetotherapy medical devices
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Annex III limitated to punture,
medical devices EC declaration of Annex II injection and/or extraction of fluids
- *MD 0102 - Non-active devices for injection, infusion, conformity (full quality medical devices
Annex V
transfusion and dialysis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0101 - Non-active devices for anaesthesia, assurance system) Annex VI

emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Annex III limitated to male latex
medical devices EC declaration of Annex II condoms
- *MD 0107 - Contraceptive medical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Annex III limitated to contact
medical devices EC declaration of Annex II lenses care products
- *MD 0108 - Non-active medical devices for conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

disinfecting, cleaning, rinsing assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation assurance system) Annex VI
(IVF) and assisted reproductive technologies (ART) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Limitated to stents
- *MD 0201 - Non-active cardiovascular implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding neurological and
- *MD 0203 - Non-active functional implants conformity (full quality Annex V neurosurgical implants
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding breast implants
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limitated to diagnostic medical
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality
assurance system)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding infusion pumps for the
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V delivery of medicines
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

(EOG), low temperature steam and

formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma x-ray, electron
beam), sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat.
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
DEKRA Certification B.V. 0344
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
Meander 1051 / P.O. Box 5185
6825 MJ ARNHEM / 6802 ED ARNHEM medical devices EC verification Annex IV
Netherlands - *MD 0101 - Non-active devices for anaesthesia, EC declaration of Annex II
emergency and intensive care conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system)
Annex VI
transfusion and dialysis EC declaration of
- *MD 0103 - Non-active orthopaedic and rehabilitation conformity (production
devices quality assurance)
- *MD 0104 - Non-active medical devices with EC declaration of
measuring function conformity (product quality
- *MD 0105 - Non-active ophthalmologic devices assurance)

- *MD 0106 - Non-active instruments

- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

(IVF) and assisted reproductive technologies (ART)

*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7001 - Medical devices incorporating medicinal

substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
ISTITUTO SUPERIORE DI SANITA' 0373
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Viale Regina Elena, 299
00161 - ROMA medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

transfusion and dialysis EC declaration of

conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system)
devices EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
measuring function EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Annex III limited to ophthalmic
medical devices EC declaration of Annex II solutions
- *MD 0105 - Non-active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0201 - Non-active cardiovascular implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V

assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC type-examination Annex III Annex III limited to injectable
- *MD 0203 - Non-active functional implants EC declaration of Annex II visco-elastic solutions for
conformity (full quality intra-articular use
Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC type-examination Annex III Annex III limited intradermal fillers
- *MD 0204 - Non-active soft tissue implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1104 - Active surgical devices conformity (full quality

assurance system)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III Limited to accelerator for hadron
therapy EC verification Annex IV therapy and related dose delivery
- *MD 1401 - Devices utilising ionizing radiation system

*MDS 7001 - Medical devices incorporating medicinal

substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam,
moist heat sterilisation, radiation
sterelisation (gamma, electron
beam)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
RISE Research Institutes of Sweden AB 0402
*MD 1200 - Devices for imaging Full quality assurance Annex II
Box 857
501 15 BORAS - *MD 1201 - Imaging devices utilising ionizing system Annex V
Sweden radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging EC declaration of Annex II
conformity (full quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1202 - Imaging devices utilising non-ionizing assurance system) Annex V

radiation EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1301 - Monitoring devices of non-vital system Annex V
physiological parameters Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II

medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II Bone-anchored implants for dental

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0203 - Non-active functional implants system Annex V and cranio-facial reconstruction
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II Bone-anchored implants for dental
- *MD 0403 - Dental implants system Annex V and cranio-facial reconstruction
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
INTERTEK SEMKO AB 0413
*MD 0100 - General non-active, non-implantable EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
Torshamnsgatan 43 Box 1103
medical devices conformity (full quality Annex V
SE-164 22 KISTA
Sweden - *MD 0101 - Non-active devices for anaesthesia, assurance system) Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
- *MD 0103 - Non-active orthopaedic and rehabilitation Product quality assurance
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0302 - Suture material and clamps

- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
- *MD 1102 - Respiratory devices, devices including EC declaration of
hyperbaric chambers for oxygen therapy, inhalation conformity (production
anaesthesia quality assurance)

- *MD 1103 - Devices for stimulation or inhibition EC declaration of

conformity (product quality
- *MD 1104 - Active surgical devices
assurance)
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
ICIM S.P.A. 0425
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
Piazza Don Enrico Mapelli, 75
20099 - Sesto San Giovanni (MI) medical devices conformity (full quality Annex V devices
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

transfusion and dialysis EC declaration of

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0302 - Suture material and clamps conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V devices
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0402 - Dental materials conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0403 - Dental implants conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V devices and hyperbaric chambers
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1106 - Active dental devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V devices
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1111 - Software conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V devices
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V devices
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V devices
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others (need to be
specified)
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
ITALCERT SRL 0426
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
Viale Sarca, 336
20126 - MILANO - *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V devices
Italy physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Exclusion of class III medical
therapy conformity (full quality Annex V devices
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Exclusion of class III medical
therapy conformity (full quality Annex V devices
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices, except surgically devices,
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
intended for transient use, in direct
transfusion and dialysis EC declaration of contact with central nervous
conformity (production system
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V devices

- *MD 0105 - Non-active ophthalmologic devices assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0203 - Non-active functional implants conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V devices
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0302 - Suture material and clamps conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V devices
instruments assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0402 - Dental materials conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1111 - Software conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V devices
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V devices
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1104 - Active surgical devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1106 - Active dental devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V devices
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V devices
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V devices
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7002 - Medical devices utilising tissues of animal Exclusion of medical devices
origin, including Regulation 722/2012 (Directive utilising tissues of animal origin
2003/32/EC up to 28.08.2013) under Commission Regulation
(EU) n. 722/2012
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
KIWA CERMET ITALIA S.P.A. 0476
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Via Cadriano, 23
40057 - Cadriano di Granarolo (BO) medical devices conformity (full quality Annex V
Italy - *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V and hyperbaric chambers for
hyperbaric chambers for oxygen therapy, inhalation assurance system) oxygen therapy
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1111 - Software conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0203 - Non-active functional implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V and devices for magnetic
radiation assurance system) resonance
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III medical devices
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III medical devices
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III medical devices
- *MD 0201 - Non-active cardiovascular implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation moist
heat sterilisation, radiation
sterilisation (gamma,xray,electron
beam), dry heat
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Eurofins Product Testing Italy S.r.l. 0477
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III Exclusion of class III medical
Via Courgnè, 21
10156 - TORINO (TO) - *MD 0401 - Non-active dental equipment and EC verification Annex IV devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
Italy
instruments EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III Exclusion of class III medical
- *MD 0402 - Dental materials EC verification Annex IV devices, except those classified in
class III only as incorporating
EC declaration of Annex II
medicinal substances, according to
conformity (full quality Annex V
Directive 2001/83/EC
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III Exclusion of class III medical
- *MD 0403 - Dental implants EC verification Annex IV devices

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices, except those classified in
- *MD 0101 - Non-active devices for anaesthesia, assurance system) class III only as incorporating
Annex VI
emergency and intensive care EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Exclusion of class III medical
medical devices EC verification Annex IV devices, except those classified in
- *MD 0102 - Non-active devices for injection, infusion, EC declaration of class III only as incorporating
Annex II
transfusion and dialysis medicinal substances, according to
conformity (full quality Annex V
Directive 2001/83/EC
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Exclusion of class III medical
medical devices EC verification Annex IV devices, except those classified in
- *MD 0105 - Non-active ophthalmologic devices class III only as incorporating
EC declaration of Annex II
medicinal substances, according to
conformity (full quality Annex V
Directive 2001/83/EC
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Exclusion of class III medical
medical devices EC verification Annex IV devices, except those classified in
- *MD 0106 - Non-active instruments class III only as incorporating
EC declaration of Annex II
medicinal substances, according to
conformity (full quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex V Directive 2001/83/EC

EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Exclusion of class III medical
medical devices EC verification Annex IV devices, except those classified in
- *MD 0107 - Contraceptive medical devices class III only as incorporating
EC declaration of Annex II
medicinal substances, according to
conformity (full quality Annex V
Directive 2001/83/EC
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Exclusion of class III medical
medical devices EC verification Annex IV devices, except those classified in
- *MD 0108 - Non-active medical devices for class III only as incorporating
EC declaration of Annex II
disinfecting, cleaning, rinsing medicinal substances, according to
conformity (full quality Annex V
Directive 2001/83/EC
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as utlising tissues of
Annex VI
EC declaration of animal origin, including
conformity (production Commission Regulation (EU) N.
quality assurance) 722/2012.

EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0203 - Non-active functional implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising tissues of animal origin,
including Commission Regulation
EC declaration of
(EU) N. 722/2012.
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III Exclusion of class III medical
- *MD 0301 - Bandages and wound dressings EC verification Annex IV devices, except those classified in
class III only as incorporating
EC declaration of Annex II
medicinal substances, according to
conformity (full quality Annex V
Directive 2001/83/EC
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III Exclusion of class III medical
- *MD 0302 - Suture material and clamps EC verification Annex IV devices

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III Exclusion of class III medical
- *MD 0303 - Other medical devices for wound care EC verification Annex IV devices, except those classified in
class III only as incorporating
EC declaration of Annex II
medicinal substances, according to
conformity (full quality Annex V
Directive 2001/83/EC
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V devices
infusion and haemopheresis assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V devices
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1104 - Active surgical devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1106 - Active dental devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V devices
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V devices
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V devices
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1111 - Software conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Exclusion of class III medical
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V devices
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V devices
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Exclusion of class III medical
therapy conformity (full quality Annex V devices
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Exclusion of class III medical
medical devices EC verification Annex IV devices, except those classified in
- *MD 0110 - Non-active medical devices for ingestion EC declaration of class III only as incorporating
Annex II
medicinal substances, according to
conformity (full quality Annex V
Directive 2001/83/EC and/or
assurance system)
Annex VI utilising tissues of animal origin,
EC declaration of
including Commission Regulation
conformity (production
(EU) N. 722/2012.
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising tissues of animal origin,
including Commission Regulation
EC declaration of
(EU) N. 722/2012.
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V devices
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Exclusion of class III medical
therapy conformity (full quality Annex V devices
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including moist heat sterilization,
aseptic processing, radiation
sterilization,ethylene oxide gas
sterilization (EOG)
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
MEDCERT ZERTIFIZIERUNGS- UND 0482
*MD 0300 - Devices for wound care EC type-examination Annex III
PRÜFUNGSGESELLSCHAFT FÜR DIE
MEDIZIN GMBH - *MD 0301 - Bandages and wound dressings EC declaration of Annex II
Pilatuspool 2 conformity (full quality Annex V
20355 HAMBURG
Germany
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
- *MD 0303 - Other medical devices for wound care Annex VI
EC declaration of
*MD 0400 - Non-active dental devices and accessories
conformity (production
- *MD 0401 - Non-active dental equipment and
quality assurance)
instruments
EC declaration of
- *MD 0402 - Dental materials
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III
- *MD 0403 - Dental implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1102 - Respiratory devices, devices including EC declaration of

hyperbaric chambers for oxygen therapy, inhalation conformity (production
anaesthesia quality assurance)
- *MD 1103 - Devices for stimulation or inhibition EC declaration of
- *MD 1104 - Active surgical devices conformity (product quality
assurance)
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0110 - Non-active medical devices for ingestion
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0101 - Non-active devices for anaesthesia, conformity (full quality Annex V
emergency and intensive care assurance system)
Annex VI
- *MD 0102 - Non-active devices for injection, infusion, EC declaration of
transfusion and dialysis conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
- *MD 0104 - Non-active medical devices with conformity (production
measuring function quality assurance)

- *MD 0105 - Non-active ophthalmologic devices EC declaration of

conformity (product quality
- *MD 0106 - Non-active instruments

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0107 - Contraceptive medical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
- *MD 0109 - Non-active devices for in vitro fertilisation conformity (production
(IVF) and assisted reproductive technologies (ART) quality assurance)

*MD 0200 - Non-active implants EC declaration of

conformity (product quality
- *MD 0202 - Non-active orthopaedic implants
assurance)
*MD 0200 - Non-active implants EC type-examination Annex III
- *MD 0203 - Non-active functional implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC type-examination Annex III
- *MD 0201 - Non-active cardiovascular implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive for active medical devices only
2006/42/EC on machinery

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7006 - Medical devices in sterile condition Including aseptic processing,

ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
MDC MEDICAL DEVICE CERTIFICATION 0483
*MD 0200 - Non-active implants Full quality assurance Annex II
GMBH
Kriegerstrasse 6 - *MD 0201 - Non-active cardiovascular implants system Annex V
70191 STUTTGART Production quality Annex VI
Germany
assurance
Product quality assurance
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0204 - Non-active soft tissue implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0203 - Non-active functional implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality Annex VI
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1402 - Devices utilising non-ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0107 - Contraceptive medical devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation Production quality Annex VI
(IVF) and assisted reproductive technologies (ART) assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices system Annex V

- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1301 - Monitoring devices of non-vital system Annex V
physiological parameters Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1302 - Monitoring devices of vital physiological system Annex V

parameters Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V
sterilisation Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1108 - Active rehabilitation devices and active system Annex V
prostheses Production quality Annex VI
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex V
transport Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1111 - Software system Annex V
Production quality
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance Annex VI
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II except hyperbaric chambers
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II except external pacemakers and
- *MD 1103 - Devices for stimulation or inhibition system Annex V heart defibrillators
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1105 - Active ophthalmologic devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7009 - Medical devices utilising biological active

coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
SLG PRÜF UND ZERTIFIZIERUNGS GMBH 0494
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices
Burgstädter Strasse 20
09232 Hartmannsdorf - *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV
Germany
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV
hyperbaric chambers for oxygen therapy, inhalation EC declaration of Annex II
anaesthesia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1104 - Active surgical devices EC verification Annex IV

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices
- *MD 1105 - Active ophthalmologic devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices
- *MD 1106 - Active dental devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1109 - Active devices for patient positioning and EC verification Annex IV
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices
- *MD 1111 - Software EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III excluding class III devices
- *MD 1201 - Imaging devices utilising ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III excluding class III devices
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III excluding class III devices
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III excluding class III devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV

parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III excluding class III devices
therapy EC verification Annex IV
- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III excluding class III devices
therapy EC verification Annex IV
- *MD 1403 - Devices for hyperthermia / hypothermia EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Eurofins Expert Services Oy 0537
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
PL 47 Kivimiehentie 4
FI-02150 Espoo. medical devices conformity (full quality Annex V
Finland - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI

devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding contact lenses,
medical devices conformity (full quality Annex V intraocular lenses and class III
- *MD 0105 - Non-active ophthalmologic devices assurance system) devices.
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding active devices for
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V sterilization and class III devices
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding active prosthesis and
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V class III devices
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive Excluding class III
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Limited to the following methods:
aseptic processing, ethylene oxide
gas sterilisation (EOG), moist heat
sterilisation, dry heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam).
*MDS 7010 - Medical devices incorporating software Excluding class III
/utilising software /controlled by software

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
CERTIQUALITY S.r.l. 0546
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
Via G. Giardino, 4
20123 - MILANO medical devices conformity (full quality Annex V devices, except those classified in
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system) class III only as incorporating
Annex VI
emergency and intensive care EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices, except those classified in
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
class III only as incorporating
transfusion and dialysis EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V devices, except those classified in
- *MD 0105 - Non-active ophthalmologic devices assurance system) Annex VI class III only as incorporating
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V devices, except those classified in

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI class III only as incorporating

EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0203 - Non-active functional implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of medicinal substances, according to

conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
EC declaration of and/or materials or being wholly or
conformity (product quality mainly absorbed
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0302 - Suture material and clamps conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V devices
instruments assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0402 - Dental materials conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0403 - Dental implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding hyperbaric chambers
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V and all devices depending on a
hyperbaric chambers for oxygen therapy, inhalation assurance system) source of electrical energy.
Annex VI
anaesthesia EC declaration of Exclusion of class III medical
conformity (production devices, except those classified in

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance) Class III only as incorporating

EC declaration of medicinal substances, according to
conformity (product quality Directive 2001/83/EC
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1111 - Software conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding medical devices
therapy conformity (full quality Annex V depending on a source of electrical
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
energy. Exclusion of class III
EC declaration of medical devices, except those
conformity (production classified in Class III only as
quality assurance) incorporating medicinal
substances, according to Directive
EC declaration of
2001/83/EC
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices, except those classified in
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
Class III only as incorporating
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V devices
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
SGS FIMKO OY 0598
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Up to class IIb only
Takomotie 8
00380 HELSINKI medical devices conformity (full quality Annex V
Finland - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Up to class IIb only
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Up to class IIb only
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Up to class IIb only

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0402 - Dental materials conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Up to class IIb only
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Up to class IIb only; III, IV:
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV Hyperbaric chambers only
hyperbaric chambers for oxygen therapy, inhalation EC declaration of Annex II
anaesthesia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC type-examination Annex III Up to class IIb only; III, IV: Nerve
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV and muscle stimulator only

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Up to class IIb only
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Up to class IIb only; III, IV: Dental
- *MD 1106 - Active dental devices EC verification Annex IV units and dental patient chairs only

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Up to class IIb only
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Up to class IIb only; III, IV:
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV Neurological and muscular
prostheses rehabilitation devices only
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Up to class IIb only
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Up to class IIb only
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III Up to class IIb only; III, IV: X-ray
- *MD 1201 - Imaging devices utilising ionizing EC verification Annex IV devices only
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III Up to class IIb only; III, IV:
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV Magnetic resonance imaging (MRI)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

radiation EC declaration of Annex II devices only

conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III Up to class IIb only
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III Up to class IIb only
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV
parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Up to class IIb only
therapy conformity (full quality Annex V
- *MD 1401 - Devices utilising ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III Up to class IIb only; III, IV: Surgical
therapy EC verification Annex IV ultrasoud devices only
- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Up to class IIb only
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Up to class IIb only
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Up to class IIb only
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Up to class IIb only
therapy conformity (full quality Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave assurance system) Annex VI
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Up to class IIb only
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Up to class IIb only
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Up to class IIb only
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MDS 7004 - Medical devices referencing the Directive Up to class IIb only
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Up to class IIb only
*MDS 7010 - Medical devices incorporating software Up to class IIb only
/utilising software /controlled by software
Berlin Cert Prüf- und Zertifizierstelle für 0633
*MD 1100 - General active medical devices EC verification Annex IV
Medizinprodukte GmbH
Dovestraße 6 - *MD 1108 - Active rehabilitation devices and active EC declaration of Annex II
10587 Berlin prostheses conformity (full quality Annex V
Germany
- *MD 1109 - Active devices for patient positioning and assurance system) Annex VI
transport EC declaration of
- *MD 1111 - Software conformity (production
quality assurance)
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis EC declaration of
conformity (product quality
- *MD 1102 - Respiratory devices, devices including
assurance)
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 0100 - General non-active, non-implantable
medical devices

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0103 - Non-active orthopaedic and rehabilitation

devices
- *MD 0106 - Non-active instruments
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas
sterilisation (EOG), moist heat
sterilisation, radiation sterilisation
(gamma)
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
NATIONAL EVALUATION CENTER OF 0653
*MD 1200 - Devices for imaging EC declaration of Annex II
QUALITY AND TECHNOLOGY IN HEALTH
S.A.- EKAPTY - *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
Smyrnis 15 radiation assurance system)
Annex VI
165 62 GLYFADA
Greece
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1200 - Devices for imaging EC declaration of Annex II

- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy conformity (full quality Annex V

- *MD 1402 - Devices utilising non-ionizing radiation assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave assurance system) Annex VI
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0101 - Non-active devices for anaesthesia, assurance system) Annex VI

emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

measuring function EC declaration of

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation assurance system) Annex VI
(IVF) and assisted reproductive technologies (ART) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Only for physiotherapy
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II

- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex VI
infusion and haemopheresis assurance system)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Respiratory devices only
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex VI
hyperbaric chambers for oxygen therapy, inhalation assurance system)
anaesthesia EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Only for physiotherapy
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MDS 7001 - Medical devices incorporating medicinal Only for MD Codes referred above

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

substances, according to Directive 2001/83/EC

*MDS 7004 - Medical devices referencing the Directive Only for MD Codes referred above
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation, dry
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam) - Only for MD
Codes referred above
*MDS 7010 - Medical devices incorporating software Only for MD Codes referred above
/utilising software /controlled by software
Eurofins Product Service GmbH 0681
*MD 0100 - General non-active, non-implantable EC type-examination Annex III excluding class III devices (valid for
Storkower Straße 38c
15526 REICHENWALDE medical devices EC verification Annex IV the complete scope)
Germany - *MD 0103 - Non-active orthopaedic and rehabilitation EC declaration of Annex II
devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices (valid for
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV the complete scope)
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices (valid for
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV the complete scope)
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
THERAPEUTIC GOODS ADMINISTRATION 0805
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
136 Narrabundah Lane
Symonston ACT medical devices conformity (full quality Annex V
Australia - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0103 - Non-active orthopaedic and rehabilitation EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

devices conformity (product quality

- *MD 0104 - Non-active medical devices with assurance)
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1105 - Active ophthalmologic devices

- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy (lithotripsy)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
NEOEMKI Nemzeti Orvostechnikai Eszköz 1011
*MD 1200 - Devices for imaging EC declaration of Annex II
Megfelel#ségértékel# és Tanúsító Korlátolt
Felel#sség# Társaság (NEOEMKI LLC) - *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
Albert Flórián út 3. A. ép radiation assurance system)
H-1097 Budapest
Hungary
EC declaration of
conformity (production
quality assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Annex III. designation excluding
medical devices conformity (full quality Annex V materials of desinfecting, cleaning
- *MD 0108 - Non-active medical devices for assurance system) and rinsing . For Annex II., V., VI.
Annex VI
disinfecting, cleaning, rinsing EC declaration of there are no limitations.
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II

medical devices conformity (full quality Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation assurance system) Annex VI
(IVF) and assisted reproductive technologies (ART) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0403 - Dental implants conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1110 - Active devices for in vitro fertilisation conformity (full quality Annex V
(IVF) and assisted reproductive therapy (ART) assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0203 - Non-active functional implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal Designation excludes products

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

origin, including Regulation 722/2012 (Directive related 2003/32/EC BSE/TSE field.

2003/32/EC up to 28.08.2013) Designation includes Annex 2 and
5.
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, 1014
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
s.p.
Pod Lisem 129 medical devices system Annex V
171 02 PRAHA 71 - Troja - *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
Czech Republic
emergency and intensive care assurance
- *MD 0102 - Non-active devices for injection, infusion, Product quality assurance
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments

- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex III
infusion and haemopheresis EC type-examination Annex IV
- *MD 1102 - Respiratory devices, devices including EC verification Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
- *MD 1103 - Devices for stimulation or inhibition Product quality assurance
- *MD 1104 - Active surgical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1105 - Active ophthalmologic devices

- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 1100 - General active medical devices EC type-examination Annex III

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others (need to be
specified)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, 1023
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
a. s. (merged with ex-NB 1390)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
T. Bati 299
medical devices conformity (full quality Annex V
Louky, 76302 ZLIN
Czech Republic - *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0105 - Non-active ophthalmologic devices assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III medical devices
- *MD 0203 - Non-active functional implants conformity (full quality Annex V and contraceptive medical devices
assurance system) of any risk classes
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding breast implants and
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V non-absorbable injection implants
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III medical devices
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy conformity (full quality Annex V

- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7006 - Medical devices in sterile condition Limited to devices sterilised by one
of the following: Aseptic filling,
Ethylene oxide sterilisation,
Radiation sterilisation, Moist and
dry heat sterilisation
*MDS 7009 - Medical devices utilising biological active Limited to devices being wholly or
coatings and/or materials or being wholly or mainly mainly absorbed
absorbed
*MDS 7010 - Medical devices incorporating software Excluding class III medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

/utilising software /controlled by software

Schweizerische Vereinigung für Qualitäts- und 1250
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Managementsysteme
Bernstrasse 103 medical devices system Annex V
3052 Zollikofen - *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
Switzerland
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0202 - Non-active orthopaedic implants system Annex V

Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding heart-lung machine
- *MD 1101 - Devices for extra-corporal circulation, system Annex V
infusion and haemopheresis Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding life sustaining devices
- *MD 1103 - Devices for stimulation or inhibition system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II without devices specifically
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V intended for monitoring of vital
parameters assurance system) physiological parameters where
Annex VI
EC declaration of the nature of variations is such that
conformity (production it could result in immediate danger
quality assurance) to the patient, for instance
variations in cardiac performance,
EC declaration of
respiration, activity of CNS
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave assurance system) Annex VI
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality
thereof assurance system)

*MDS 7004 - Medical devices referencing the Directive

2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas
sterilisation (EOG), low
temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), plasma
sterilization
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7010 - Medical devices incorporating software

/utilising software /controlled by software
ENTE CERTIFICAZIONE MACCHINE SRL 1282
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III devices
Via Ca’ Bella, 243/A - loc. Castello di Serravalle
40053 Valsamoggia (BO) medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III devices
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III devices
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III devices
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III devices
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

physiological parameters assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III devices
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III devices
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7010 - Medical devices incorporating software

/utilising software /controlled by software
SLOVENIAN INSTITUTE OF QUALITY AND 1304
*MD 1100 - General active medical devices EC type-examination Annex III Annex III and IV for lasers only
METROLOGY - SIQ
Mašera - Spasi#eva ulica 10 - *MD 1105 - Active ophthalmologic devices EC verification Annex IV
1000 LJUBLJANA
EC declaration of Annex II
Slovenia
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II Only infant incubators included
- *MD 1101 - Devices for extra-corporal circulation, system Annex V
infusion and haemopheresis Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II Only respiratory devices included
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC type-examination Annex III Annex III and IV for lasers only
- *MD 1106 - Active dental devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
system

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1107 - Active devices for disinfection and Production quality Annex V
sterilisation assurance Annex VI
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV
parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Included only devices for injection,
medical devices system Annex V infusion and transfusion
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

substances, according to Directive 2001/83/EC

*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Excluding formaldehyde
sterilisation
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
BUREAU VERITAS ITALIA S.P.A. 1370
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
Viale Monza, 347
20126 - MILANO (MI) medical devices conformity (full quality Annex V devices
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V devices
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0402 - Dental materials conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0403 - Dental implants conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V devices - excluding hyperbaric
hyperbaric chambers for oxygen therapy, inhalation assurance system) chambers for oxygen therapy
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1104 - Active surgical devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1106 - Active dental devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V devices
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V devices
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1111 - Software conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Exclusion of class III medical
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V devices
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V devices
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V devices
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Exclusion of class III medical
therapy conformity (full quality Annex V devices
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V devices
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V devices
thereof assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas
sterilization (EOG), moist heat
sterilization, radiation sterilization
(gamma, x-ray, electron beam),
low temperature steam.
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
POLSKIE CENTRUM BADAN I 1434
*MD 1100 - General active medical devices EC type-examination Annex III
CERTYFIKACJI S.A.
ul. Pu#awska 469 - *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV
02-844 Warszawa infusion and haemopheresis EC declaration of Annex II
Poland
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
- *MD 1103 - Devices for stimulation or inhibition conformity (production
- *MD 1104 - Active surgical devices quality assurance)

- *MD 1105 - Active ophthalmologic devices EC declaration of

conformity (product quality
- *MD 1106 - Active dental devices
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1107 - Active devices for disinfection and

sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

transfusion and dialysis

- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0110 - Non-active medical devices for ingestion
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
- *MD 0401 - Non-active dental equipment and

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

instruments
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
SGS Belgium NV 1639
*MD 1200 - Devices for imaging EC declaration of Annex II
Noorderlaan 87
BE-2030 Antwerpen - *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
Belgium radiation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

radiation assurance system)

EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1401 - Devices utilising ionizing radiation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system)
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave assurance system)
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system)
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system)
devices EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
measuring function EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0107 - Contraceptive medical devices assurance system)

EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation assurance system)
(IVF) and assisted reproductive technologies (ART) EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding heartvalves
- *MD 0201 - Non-active cardiovascular implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding breast implants
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0200 - Non-active implants EC declaration of Annex II

- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0203 - Non-active functional implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

prostheses assurance system)

EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
anaesthesia EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II

- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1110 - Active devices for in vitro fertilisation conformity (full quality Annex V
(IVF) and assisted reproductive therapy (ART) assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
TURKISH STANDARDS INSTITUTION (TSE) 1783
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Necatibey Cad. No. 112, 06100 Bakanliklar
Ankara medical devices conformity (full quality Annex V
Turkey - *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0104 - Non-active medical devices with

measuring function
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1111 - Software
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7006 - Medical devices in sterile condition Only, ethylene oxide gas
sterilisation (EOG), moist heat

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation, radiation sterilisation

and dry heat sterilisation.
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
DARE!! Services B.V. 1912
*MD 1100 - General active medical devices EC type-examination Annex III Limited to devices for
Vijzelmolenlaan 7
NL-3447 GX Woerden - *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV administration and removal of
Netherlands infusion and haemopheresis substances Limited to non sterile
EC declaration of Annex II
class Im, IIa and IIb devices
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV and IIb devices inhalation
hyperbaric chambers for oxygen therapy, inhalation anaesthesia, lung ventilators and
EC declaration of Annex II
anaesthesia heart-lung machines are excluded
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV and IIb devices

EC declaration of Annex II
conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1104 - Active surgical devices EC verification Annex IV and IIb devices

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV and IIb devices
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV and IIb devices
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV and IIb devices
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV and IIb devices
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV and IIb devices
parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III Limited to non sterile class Im, IIa
therapy EC verification Annex IV and IIb devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II

conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1105 - Active ophthalmologic devices EC verification Annex IV and IIb devices

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1106 - Active dental devices EC verification Annex IV and IIb devices

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to non sterile class Im, IIa
- *MD 1111 - Software conformity (full quality and IIb devices
assurance system)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III Limited to non sterile class Im, IIa
therapy EC verification Annex IV and IIb devices
- *MD 1403 - Devices for hyperthermia / hypothermia
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MDS 7004 - Medical devices referencing the Directive Limited to non sterile class Im, IIa
2006/42/EC on machinery and IIb devices
*MDS 7010 - Medical devices incorporating software Limited to non sterile class Im, IIa
/utilising software /controlled by software and IIb devices
TUV Rheinland Italia SRL 1936
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
Via Mattei, 3
20010 - Pogliano Milanese (MI) medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V

- *MD 0106 - Non-active instruments assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV
infusion and haemopheresis EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

prostheses EC declaration of Annex II

conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV and hyperbaric chambers for
hyperbaric chambers for oxygen therapy, inhalation oxygen therapy
EC declaration of Annex II
anaesthesia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1104 - Active surgical devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1106 - Active dental devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III Excluding class III medical devices
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1300 - Monitoring devices EC type-examination Annex III

- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV
parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1401 - Devices utilising ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC verification Annex IV Excluding class III medical devices
therapy EC declaration of Annex II
- *MD 1402 - Devices utilising non-ionizing radiation conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III medical devices
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam
sterilisation, moist heat
sterilisation, radiation sterilisation
(gamma, x-ray, electron beam)
*MDS 7009 - Medical devices utilising biological active

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

coatings and/or materials or being wholly or mainly

absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Kiwa Belgelendirme Hizmetleri A.#. 1984
*MD 1200 - Devices for imaging EC declaration of Annex II
#TOSB 9. CAD. NO:15 Tepeören Tuzla /
#STANBUL - *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
Istanbul radiation assurance system)
Turkey
- *MD 1202 - Imaging devices utilising non-ionizing EC declaration of
radiation conformity (production
quality assurance)
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments

- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0110 - Non-active medical devices for ingestion
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1111 - Software

- *MD 1112 - Medical gas supply systems and parts
thereof
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1108 - Active rehabilitation devices and active
prostheses
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

formaldehyde sterilisation, moist

heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam)
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Szutest Uygunluk De#erlendirme A.#. 2195
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Tatl#su Mahallesi Akif #nan Sk. No:1/1
Ümraniye / #stanbul medical devices system Annex V
#STANBUL - *MD 0101 - Non-active devices for anaesthesia, Production quality
Turkey
emergency and intensive care assurance
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0203 - Non-active functional implants

- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex V
infusion and haemopheresis Production quality
- *MD 1102 - Respiratory devices, devices including assurance
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1106 - Active dental devices

- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1111 - Software
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex V
radiation Production quality
- *MD 1202 - Imaging devices utilising non-ionizing assurance
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7006 - Medical devices in sterile condition

*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
3EC International a.s. 2265
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
3EC International a.s. Hranicna 18 Bratislava
82105 SLOVAKIA medical devices conformity (full quality Annex V
Bratislava 82105 - *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
Slovakia
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
- *MD 0102 - Non-active devices for injection, infusion, Product quality assurance
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0107 - Contraceptive medical devices

- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1104 - Active surgical devices

- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1404 - Devices for (extracorporal) shock-wave

therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal excluding Regulation 722/2012
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
TUV NORD Polska Sp. z o.o 2274
*MD 1300 - Monitoring devices Full quality assurance Annex II
ul. Mickiewicza 29
40-085 Katowice - *MD 1301 - Monitoring devices of non-vital system Annex V
Poland physiological parameters Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1302 - Monitoring devices of vital physiological system Annex V
parameters Production quality Annex VI
assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II

medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0108 - Non-active medical devices for assurance system) Annex VI

disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1402 - Devices utilising non-ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
conformity (full quality
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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0303 - Other medical devices for wound care assurance system) Annex V
EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality
assurance system)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality
assurance system)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality
assurance system)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II .
- *MD 1101 - Devices for extra-corporal circulation, system Annex V
infusion and haemopheresis Production quality Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1103 - Devices for stimulation or inhibition system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex V
transport Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II without acitive prostheses
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7006 - Medical devices in sterile condition
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
UDEM Uluslararasi Belgelendirme Denetim 2292
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Egitim Merkezi San. ve Tic. A.#.
Mutlukent Mahallesi 2073 Sokak No:10 medical devices conformity (full quality Annex V
Umitkoy-CANKAYA - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Ankara
Turkey
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0104 - Non-active medical devices with

measuring function
- *MD 0105 - Non-active ophthalmologic devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments

- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0110 - Non-active medical devices for ingestion
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1108 - Active rehabilitation devices and active

prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
- *MD 1103 - Devices for stimulation or inhibition
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

radiation sterilisation (gamma,

x-ray, electron beam)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
CE Certiso Orvos- és Kórháztechnikai 2409
*MD 1200 - Devices for imaging EC declaration of Annex II
Ellen#rz# és Tanúsító Kft.
Erd# u.101. - *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
Budakeszi radiation assurance system)
Annex VI
Hungary
*MD 1300 - Monitoring devices EC declaration of
conformity (production
- *MD 1301 - Monitoring devices of non-vital
quality assurance)
physiological parameters
EC declaration of
- *MD 1302 - Monitoring devices of vital physiological
conformity (product quality
parameters
assurance)
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
- *MD 0110 - Non-active medical devices for ingestion
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1108 - Active rehabilitation devices and active

prostheses
- *MD 1111 - Software
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
*MDS 7001 - Medical devices incorporating medicinal regarding Annex II, V, VI
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive regarding Annex II, V, VI
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition regarding Annex II, V, VI Including
aseptic processing, ethylene oxide
gas sterilisation (EOG), radiation
sterilization (gamma,x-ray, electron
beam), moist heat sterilization
*MDS 7009 - Medical devices utilising biological active regarding Annex II, V, VI
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software regarding Annex II, V, VI
/utilising software /controlled by software
DNV Product Assurance AS 2460
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Veritasveien 3

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
1363 Høvik
medical devices conformity (full quality Annex V
Norway
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0103 - Non-active orthopaedic and rehabilitation

devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories EC verification Annex IV

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0401 - Non-active dental equipment and EC declaration of Annex II

instruments conformity (full quality Annex V
- *MD 0402 - Dental materials assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
*MD 1100 - General active medical devices
EC declaration of
- *MD 1101 - Devices for extra-corporal circulation,
conformity (production
infusion and haemopheresis
quality assurance)
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1112 - Medical gas supply systems and parts

thereof
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7004 - Medical devices referencing the Directive

2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others.
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Notice Belgelendirme, Muayene ve Denetim 2764
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
Hizmetleri Anonim #irketi
Esentepe Mahallesi Milangaz Caddesi No:75 - *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
A/92 Kartal/#stanbul instruments assurance system)
Istanbul
Turkey
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Only infusion devices
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II excluding hyperbaric chambers for
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V oxygen therapy
hyperbaric chambers for oxygen therapy, inhalation assurance system)
anaesthesia EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1300 - Monitoring devices EC declaration of Annex II

- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system)
transfusion and dialysis EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
measuring function EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0203 - Non-active functional implants conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Only felts and similar technologies
- *MD 0201 - Non-active cardiovascular implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0300 - Devices for wound care EC declaration of Annex II

- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic, processing,
ethylene oxide gas, sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
BSI Group The Netherlands B.V. 2797
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Say Building, John M. Keynesplein 9, 1066 EP
Amsterdam medical devices conformity (full quality Annex V
Netherlands - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0103 - Non-active orthopaedic and rehabilitation EC declaration of

devices conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0104 - Non-active medical devices with assurance)

measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
- *MD 0110 - Non-active medical devices for ingestion
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

infusion and haemopheresis

- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1302 - Monitoring devices of vital physiological

parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
G.F.I. Health Technology Certification Ltd 2803
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Except Class III Medical Devices
Jacovides Tower 81-83 Grivas Digenis Avenue
1090 Nicosia medical devices conformity (full quality Annex V
Cyprus - *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Except Class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system)
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Except Class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system)
devices EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Except Class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
measuring function EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Except Class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
EC declaration of

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Except Class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Male Condoms only
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Except Class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Respiratory Devices only, Except
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V Class III Medical Devices
hyperbaric chambers for oxygen therapy, inhalation assurance system)
anaesthesia EC declaration of
conformity (production
quality assurance)

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II Except Class III Medical Devices
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Except Class III Medical Devices
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Except Class III Medical Devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Except Class III Medical Devices
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Except Class III Medical Devices
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
EC declaration of

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilization
(EOG), moist heat sterilization,
radiation sterilization
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
bqs. s.r.o. 2854
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Medical devices of class I sterile,
Študentská 1641/12
Tren#ín, 911 01 medical devices conformity (full quality Annex V class I with measuring function,
Slovakia - *MD 0101 - Non-active devices for anaesthesia, assurance system) class IIa and class IIb
emergency and intensive care EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Medical devices of class I sterile,
medical devices conformity (full quality Annex V class I with measuring function,
- *MD 0102 - Non-active devices for injection, infusion, assurance system) class IIa and class IIb
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Medical devices of class I sterile,
medical devices conformity (full quality Annex V class I with measuring function,
- *MD 0104 - Non-active medical devices with assurance system) class IIa and class IIb
measuring function EC declaration of
conformity (production
quality assurance)

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Medical devices of class I sterile,
medical devices conformity (full quality Annex V class I with measuring function,
- *MD 0105 - Non-active ophthalmologic devices assurance system) class IIa and class IIb
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Medical devices of class I sterile,
medical devices conformity (full quality Annex V class I with measuring function,
- *MD 0106 - Non-active instruments assurance system) class IIa and class IIb
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Medical devices of class I sterile,
- *MD 0402 - Dental materials conformity (full quality Annex V class IIa and class IIb
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Medical devices of class IIa and
- *MD 0403 - Dental implants conformity (full quality Annex V class IIb
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Medical devices of class IIa and
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V class IIb
infusion and haemopheresis assurance system)
EC declaration of

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Medical devices of class IIa and
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V class IIb excluding hyperbaric
hyperbaric chambers for oxygen therapy, inhalation assurance system) chambers
anaesthesia EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Medical devices of class IIa and
- *MD 1106 - Active dental devices conformity (full quality Annex V class IIb
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Medical devices of class I sterile,
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V class I with measuring function,
physiological parameters assurance system) class IIa and class IIb
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Medical devices of class IIa and
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V class IIb
parameters assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Medical devices of class IIa and
therapy conformity (full quality Annex V class IIb

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1402 - Devices utilising non-ionizing radiation assurance system)

EC declaration of
conformity (production
quality assurance)
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software

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