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EUDAMED update: Nov 12, 2024
CN-MF-000028354GenSure Biotech Inc. is a medical device manufacturer registered in EUDAMED. The company has 52 devices on the EU market across 2 countries. It holds 7 valid CE certificates. Headquartered in Shanghai, China. Explore the regulatory profile, devices and certificates on MD Atlas.
SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →CN-MF-000028354SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →2 approved members
Certificate 6211186TD01Rev. 0Certificate type
Technical documentation
Notified body
DEKRA Certification B.V.
Version
1
Valid from
1/20/2026
Valid until
1/1/2031
Certificate 6211186CE01Rev. 0Certificate type
Quality management system
Notified body
DEKRA Certification B.V.
Version
1
Valid from
1/20/2026
Valid until
1/1/2031
Certificate V13 126886 0002Rev. Rev. 00Certificate type
Quality management system
Notified body
TÜV SÜD Product Service GmbH
Version
1
Valid from
7/16/2025
Valid until
7/15/2030
Certificate V76 126886 0006Rev. Rev. 00Certificate type
Technical documentation
Notified body
TÜV SÜD Product Service GmbH
Version
1
Valid from
7/14/2025
Valid until
7/13/2030
Certificate V76 126886 0003Rev. Rev. 00Certificate type
Technical documentation
Notified body
TÜV SÜD Product Service GmbH
Version
1
Valid from
7/16/2025
Valid until
7/15/2030
Showing 1–25 of 52 devices.
| Trade name | Reference / catalog number | UDI-DI code | Quantity | Status |
|---|---|---|---|---|
| COVID-19/Flu A+B Ag Rapid Test | P2007C01 | 16976838230531 | 1 | On the market |
| COVID-19/Flu A+B Ag Rapid Test | P2007C20 | 16976838230562 | 20 | On the market |
| COVID-19/Flu A+B Ag Rapid Test | P2007C05 | 16976838230555 | 5 | On the market |
| COVID-19/Flu A+B Ag Rapid Test | P2007C02 | 16976838230548 | 2 | On the market |
| COVID-19/RSV/Flu A+B Ag Rapid Test | P2081C02 | 16976838230593 | 2 | On the market |
| COVID-19/RSV/Flu A+B Ag Rapid Test | P2081C01 | 16976838230586 | 1 | On the market |
| COVID-19/RSV/Flu A+B Ag Rapid Test | P2081C20 | 16976838230616 | 20 | On the market |
| COVID-19/RSV/Flu A+B Ag Rapid Test | P2081C05 | 16976838230609 | 5 | On the market |
| Y2016M02 | Y2016M02 | 16976838235024 | 2 | On the market |
| Y2016M05 | Y2016M05 | 16976838235048 | 5 | On the market |
| Y2016S50 | Y2016S50 | 16976838235130 | 50 | On the market |
| Y2016M03 | Y2016M03 | 16976838235031 | 3 | On the market |
| Y2016S10 | Y2016S10 | 16976838235116 | 10 | On the market |
| Y2016C03 | Y2016C03 | 16976838235079 | 3 | On the market |
| Y2016M01 | Y2016M01 | 16976838235017 | 1 | On the market |
| Y2016M25 | Y2016M25 | 16976838235055 | 25 | On the market |
| Y2016S25 | Y2016S25 | 16976838235123 | 25 | On the market |
| Y2016C05 | Y2016C05 | 16976838235086 | 5 | On the market |
| Y2016C25 | Y2016C25 | 16976838235093 | 25 | On the market |
| Y2011M02 | Y2011M02 | 16976838235154 | 2 | On the market |
| Y2011M05 | Y2011M05 | 16976838235178 | 5 | On the market |
| Y2011C05 | Y2011C05 | 16976838235222 | 4 | On the market |
| Y2011C25 | Y2011C25 | 16976838235239 | 25 | On the market |
| Y2011M07 | Y2011M07 | 16976838235185 | 6 | On the market |
| Y2011M03 | Y2011M03 | 16976838235161 | 3 | On the market |
Devices placed in 2 countries
1 EU importer places this manufacturer's devices
1 authorised representative routes this manufacturer's devices