Chembio Biosynex Diagnostics (Hangzhou) Inc.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000039047
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
Company details
- EUDAMED SRN
- CN-MF-000039047
- EU VAT number
- 91330110MACKWQPT9N
- EUDAMED status
- Active
- EUDAMED registered name
- Chembio Biosynex Diagnostics (Hangzhou) Inc.
- Registered address
- 3rd Floor, Building 2, No.17, Futai Road, Zhongtai Street, Yuhang District, 311121, Hangzhou, China
- [email protected]
- PRRC contact
- Juanhong Liu
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 2next expiry 17 Jun 2031
TÜV SÜD Product Service GmbH 0123 2 certificates
- V76 122528 0002 Active
Technical documentation EU IVDR
- Issued
- 18 Jun 2026
- Expires
- 17 Jun 2031
- V76 122528 0003 Active
Technical documentation EU IVDR
- Issued
- 18 Jun 2026
- Expires
- 17 Jun 2031
Frequently asked questions
How many devices does Chembio Biosynex Diagnostics (Hangzhou) Inc. have in the registry?
The registry currently lists 3 devices for Chembio Biosynex Diagnostics (Hangzhou) Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chembio Biosynex Diagnostics (Hangzhou) Inc.'s devices?
Among its 3 most recently registered devices, Chembio Biosynex Diagnostics (Hangzhou) Inc. has devices listed in EUDAMED (3 devices).
What risk classes do Chembio Biosynex Diagnostics (Hangzhou) Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Chembio Biosynex Diagnostics (Hangzhou) Inc.'s devices are IVDR Class B. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Chembio Biosynex Diagnostics (Hangzhou) Inc.?
EUDAMED lists 2 certificates for Chembio Biosynex Diagnostics (Hangzhou) Inc. (technical documentation) under IVDR. 2 are recorded with the status issued. The most recent was issued on 18 Jun 2026.
What are the newest devices from Chembio Biosynex Diagnostics (Hangzhou) Inc. in the registry?
The most recently registered devices listed for Chembio Biosynex Diagnostics (Hangzhou) Inc. include BIOSYNEX.