GenSure Flu A+B Ag Rapid Test
by GenSure Biotech Inc. China EUDAMED
Ref P2018C05 EMDN W0105099004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697683823P201800F4 | Date18 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- V76 126886 0006 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 14 Jul 2025
- Expires
- 13 Jul 2030
Specification
- Device Name
- Flu A+B Ag Rapid Test
- Model / Reference
- P2018C05
- Primary DI / UDI-DI
- 16976838230326
- Basic UDI-DI
- 697683823P201800F4
- EMDN Code
- W0105099004 Influenza a and /or b - rt & poc
- Device Class
- Class C
- Market of Registration
- Cyprus
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 16976838230326|697683823P201800F4