GenSure HCG Pregnancy Rapid Test
by GenSure Biotech Inc. China EUDAMED
Ref P2016C05Model P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50 EMDN W0102160302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697683823P201600ES | Date3 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- V76 126886 0004 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 16 Jul 2025
- Expires
- 15 Jul 2030
Specification
- Device Name
- HCG Pregnancy Rapid Test
- Model / Reference
- P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50, Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50
- Primary DI / UDI-DI
- 16976838230098
- Basic UDI-DI
- 697683823P201600ES
- EMDN Code
- W0102160302 Hcg - rt & poc
- Device Class
- Class B
- Market of Registration
- Spain
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 16976838230098|697683823P201600ES