HIV (1+2) Antibody Rapid Test
by NewScen Coast Bio-Pharmaceutical Co., Ltd. China EUDAMED
Ref HIV3-29200201000Model HIV3-29204017000
EMDN W0105090302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69401314HIV002CG | Date24 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
EU market availability
Available in 14 countries, as listed in EUDAMED:
- Denmark
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Latvia
- Luxembourg
- Netherlands
- Poland
- Portugal
- Spain
- Sweden
Certificates
- V76 095791 0014 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 4 Aug 2025
- Expires
- 3 Aug 2030
Specification
- Device Name
- HIV (1+2) Antibody Rapid Test
- Model / Reference
- HIV3-29204017000, HIV3-29200201000
- Primary DI / UDI-DI
- 06940131405098
- Basic UDI-DI
- 69401314HIV002CG
- Direct Marketing DI
- 06940131405098
- EMDN Code
- W0105090302 HIV 1 / 2 - rt & poc
- Device Class
- Class D
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000021934
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from NewScen Coast Bio-Pharmaceutical Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 7c2e4cb0-9a86-4219-9358-875d4b293aed