EU Quality Management System Certificate
Regulation (EU) 2017/745, Annex IX Chapter I and III
MDR 736670 R000
MDR 736670 R000
Manufacturer: Shenzhen HugeMed Medical Technical Development Co.,Ltd.
Address:
415, 416-1, 516-1, Building 2, No. 1, Mawu Road,
Baoan Community,
Yuanshan Street,
Longgang District,
Shenzhen
Guangdong
518115
China
Single Registration Number: CN-MF-000010895
EU Authorised Representative: Shanghai International Holding Corp. GmbH (Europe)
Address:
Eiffestrasse 80
20537 Hamburg
Germany
Scope: See attached Device Schedule
On the basis of our examination of the quality system in accordance with Regulation (EU) 2017/745, Annex IX
Chapter I and III, the quality system meets the requirements of the Regulation. For the placing on the market of
Class III devices, and Class IIb implantable devices that are not considered well-established technologies as specified
in Article 52(4) an additional Annex IX Chapter II certificate is required.
For and on behalf of BSI, a Notified Body for the above Regulation (Notified Body Number 2797):
Graeme Tunbridge, Senior Vice President Medical Devices
First
First Issue
Issue Date:
Date: 2021-12-06
2021-12-06 Starting
Starting Validity
Validity Date:
Date: 2023-06-01
2023-06-01
Current
Current Issue
Issue Date:
Date: 2023-06-01
2023-06-01 Expiry
Expiry Date:
Date: 2026-12-05
2026-12-05
Page 1 of 3
Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements of the Regulation as demonstrated
through the required surveillance activities of the Notified Body.
This certificate was issued electronically and is bound by the conditions of the contract.
NB Contact: BSI Group The Netherlands B.V., Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands. Tel: + 31 (0) 20 346 07 80
Corporate Contact: BSI Group Assurance Limited, registered in England under number 05435540 at 389 Chiswick High Road, London, W4 4AL, UK.
A Member of the BSI Group of Companies.
EU Quality Management System Certificate
Regulation (EU) 2017/745, Annex IX Chapter I and III
MDR 736670 R000
Device Schedule: Class IIa, Custom-made and other devices
Device(s) Risk Classification
Single Use Laryngoscope Blade Class Is
Flexible Video Ureterorenoscope Class IIa
Single-use Rhinolaryngoscope Class IIa
Single-use Choledochoscopes Class IIa
Single-use Cystoscope Class IIa
Single-use Bronchoscope Class IIa
For Class Is devices, the Notified Body conformity assessment is limited to the aspects relating to establishing, securing and
maintaining sterile conditions.
First Issue Date: 2021-12-06 Starting Validity Date: 2023-06-01
Current Issue Date: 2023-06-01 Expiry Date: 2026-12-05
Page 2 of 3
Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements of the Regulation as demonstrated
through the required surveillance activities of the Notified Body.
This certificate was issued electronically and is bound by the conditions of the contract.
NB Contact: BSI Group The Netherlands B.V., Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands. Tel: + 31 (0) 20 346 07 80
Corporate Contact: BSI Group Assurance Limited, registered in England under number 05435540 at 389 Chiswick High Road, London, W4 4AL, UK.
A Member of the BSI Group of Companies.
EU Quality Management System Certificate
Regulation (EU) 2017/745, Annex IX Chapter I and III
MDR 736670 R000
Certificate History
(References to applicable Common Specifications, Harmonized Standards complied with, and the relevant test and audit reports that support
any of the below certificate changes may be requested from Certificate.Verification@bsigroup.com)
Date Reference number Action
2021-12-06 3293896 Issued.
2022-03-16 3642475 Supplemented – Addition of Flexible Video
Ureterorenoscope devices.
Amended - Correction to Certificate expiry date to reflect 5
years
Current 30000391 Supplemented – Addition of Single-use RhinoLaryngoscope,
Single-use Choledochoscope, Single-use Cystoscope,
Single-use Bronchoscope
Amended - Change of legal manufacture address to
415, 416-1, 516-1, Building 2, No. 1, Mawu Road,
Baoan Community,
Yuanshan Street,
Longgang District,
Shenzhen
Guangdong
518115
China
First Issue Date: 2021-12-06 Starting Validity Date: 2023-06-01
Current Issue Date: 2023-06-01 Expiry Date: 2026-12-05
Page 3 of 3
Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements of the Regulation as demonstrated
through the required surveillance activities of the Notified Body.
This certificate was issued electronically and is bound by the conditions of the contract.
NB Contact: BSI Group The Netherlands B.V., Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands. Tel: + 31 (0) 20 346 07 80
Corporate Contact: BSI Group Assurance Limited, registered in England under number 05435540 at 389 Chiswick High Road, London, W4 4AL, UK.
A Member of the BSI Group of Companies.
