DIAGOTEC Strep A Rapid Test
by GenSure Biotech Inc. China EUDAMED
Ref P2019C01 EMDN W0105090103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697683823P201900F9 | Date18 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- V76 126886 0005 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 11 Jul 2025
- Expires
- 10 Jul 2030
Specification
- Device Name
- Strep A Rapid Test
- Model / Reference
- P2019C01
- Primary DI / UDI-DI
- 06976838234914
- Basic UDI-DI
- 697683823P201900F9
- EMDN Code
- W0105090103 Strep. a - rt & poc
- Device Class
- Class C
- Market of Registration
- Poland
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 (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06976838234914|697683823P201900F9