EC DECLARATION OF CONFORMITY FOR MUCUS
EXTRACTORS AND SPECIMEN TRAPS
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
concerning Medical Devices
Legal Name: IVOR SHAW LIMITED
Trade Name: Pennine Healthcare
Manufacturer SRN: GB-MF-000004160
Business Address: 300 City Gate
London Road
Derby
DE24 8WY
United Kingdom
EU Authorised
Representative (AR): Advena Ltd. Tower Business Centre,
2nd Floor, Tower Street, Swatar, BKR 4013, Malta
EU AR SRN: MT-AR-000000234
Product Name: Mucus Extractors and Mucus Specimen Traps
Product Codes: Refer to Appendix 2
Device Classification: Class Is, Rule 1 and 5 (Indent 1) according to Annex VIII, MDR (EU) 2017/745
Common Specifications: N/A
Intended use: Pennine’s Mucus Extractors and Specimen Traps are a single use, covered plastic
receptacle and associated tubing, containing no additives intended to be used for
the aspiration, and/or collection of mucus/sputum specimens required for further
examination. To be used on all patient populations, by clinician or suitably trained
person, in a clinical setting.
Basic UDI-DI: UDI-DI - 5033241MUCUSEXTRACTORSR8
Notified Body: BSI Group The Netherlands B.V
Notified Body Certificate
Number: 2797
MDR Certificate Number: 766979
Conformity Assessment Annex IX Chapters I and III of EU MDR 2017/745
Route:
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GMDN: 62853: Oropharyngeal secretion specimen suction kit. A collection of devices
intended exclusively for professional use to obtain by suction a mucus/sputum
specimen from the oropharynx of a neonate for microbiological examination; it
might in addition be used to clear mucus from the oropharynx to assist respiration.
It consists of a catheter/tube intended to be inserted orally, a piece of suction
tubing intended to be attached to an appropriate pump (not included), an empty
specimen collection container, and appropriate adapters/lids. This is a single-use
device
EMDN: R05010301: Respiratory and anaesthesia devices. Single chamber mucous
membrane aspirators.
We hereby declare that the medical devices listed above meet the provision of the Regulation (EU) MDR 2017/745
for medical devices. This declaration of conformity is issued under the sole responsibility of Ivor Shaw Limited
trading as Pennine Healthcare.
Signed By: Date: 06/July/2023
Name: Arun Mahendran Position: Head of Regulatory Affairs
Place: Derby, United Kingdom
On behalf of IVOR SHAW LTD t/a Pennine Healthcare, Derby, United Kingdom.
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Appendix 1 Applicable Standards:
Standard/Document Description
Name
(EU) 2017/745 Medical Device Regulation
SI 2002 No 618, as (UK) Medical Devices Regulations
amended
EN ISO 13485:2016 Medical Devices–Quality Management Systems–Requirements for regulatory purpose
EN ISO 14971:2019 Medical Devices–Application of Risk Management to medical device
EN ISO 10993-1:2018 Biological evaluation of medical devices–Part 1: Evaluation and Testing within a risk
management process
EN ISO 14644-1:2015 Cleanrooms and associated controlled environments–Part 1: Classification of air
cleanliness by particle contamination
EN ISO 20417:2021 Information supplied by the manufacturer of medical device
EN ISO 15223-1:2021 Medical Devices–Symbols to be used with medical device labels, labelling and
information to be supplied–Part 1: General Requirements
EN ISO 62366-1:2015 Medical Devices–Part 1: Application of usability engineering to medical devices
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems.
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
EN 6256:2021 Packaging for sterile medical devices
EN ISO 20696:2018 Sterile Urethral Catheters for Single Use
EN ISO 11607-1:2019 Packaging for terminally sterilized medical devices. Requirements for materials, sterile
barrier systems and packaging systems.
EN ISO 11607-2:2019 Packaging for terminally sterilized medical devices. Validation requirements for
forming, sealing and assembly process.
Appendix 2 Product List:
Product Code Description UDI-DI
Mucus Extractor 20ml, 8fg x 33cm tube, with patient label and Unit: 05033241021843
ME-8108
spare screw cap Outer: 05033241110646
Mucus Extractor 20ml, 10fg x 33cm tube, with patient label and Unit: 05033241021850
ME-8110
spare screw cap Outer: 05033241110653
Mucus Extractor 20ml, 12fg x 33cm tube, with patient label and Unit: 05033241021867
ME-8112
spare screw cap Outer: 05033241110660
Mucus Extractor 20ml, 14fg x 33cm tube, with patient label and Unit: 05033241021874
ME-8114
spare screw cap Outer: 05033241110677
Mucus Extractor 20ml, 8fg x 33cm tube, VC, with patient label and Unit: 05033241021881
ME-9108
spare screw cap Outer: 05033241110684
Mucus Extractor 20ml, 10fg x 33cm tube, VC, with patient label Unit: 05033241021898
ME-9110
and spare screw cap Outer: 05033241110691
Mucus Extractor 20ml, 12fg x 33cm tube, VC, with patient label Unit: 05033241021904
ME-9112
and spare screw cap Outer: 05033241110707
Mucus Extractor 20ml, 14fg x 33cm tube, VC, with patient label Unit: 05033241021911
ME-9114
and spare screw cap Outer: 05033241110714
Unit: 05033241021928
ME-9214 Mucus Extractor 14fg, 500mm, 20ml, VC
Outer: 05033241000794
Mucus Specimen Trap 30ml, 20fg x 14cm, with patient label and Unit: 05033241022116
MST-3000
spare screw cap Outer: 05033241110035
Mucus Specimen Trap 30ml, 20fg x 6cm, with patient label and Unit: 05033241022147
MST-3070
spare screw cap Outer: 05033241110042
Mucus Specimen Trap 30ml, 18fg x 29cm, with patient label and Unit: 05033241022178
MST-3180
spare screw cap Outer: 05033241110059
Unit: 05033241022185
MST-4000 Mucus specimen trap 70ml Screw cap and spare screw cap
Outer: 05033241110394
Unit: 05033241022215
MST-4000/S Mucus specimen trap 70ml Screw cap and spare screw cap
Outer: 05033241110486
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Unit: 05033241022222
MST-5000 Mucus specimen trap 20ml 16fg tube VC2 - screw cap & spare
Outer: 05033241110417
Unit: 05033241022239
MST-7000 Mucus specimen trap 14fg with male connector
Outer: 05033241110479
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