COVID-19/Flu A+B Ag Rapid Test
by GenSure Biotech Inc. China EUDAMED
Ref P2007C20Model P2007C01, P2007C02, P2007C05, P2007C20 EMDN W0105090601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697683823P200700EQ | Date3 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- 6211186CE01 Issued
Quality management system EU IVDR
- Notified body
- Notified body 0344
- Issued
- 20 Jan 2026
- Expires
- 1 Jan 2031
- 6211186TD01 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 0344
- Issued
- 20 Jan 2026
- Expires
- 1 Jan 2031
Specification
- Model / Reference
- P2007C01, P2007C02, P2007C05, P2007C20
- Primary DI / UDI-DI
- 16976838230562
- Basic UDI-DI
- 697683823P200700EQ
- EMDN Code
- W0105090601 Coronavirus / influenza - rt & poc
- Device Class
- Class C
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000028354
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from GenSure Biotech Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED b282c47a-6f60-44ae-b465-fe97b908a8e4