Generic Hbv Viral Load Ver 2.0
by Hain Lifescience GmbH Germany EUDAMED
Ref TR004.2-250IC EMDN W0105020216
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number40490550300001100TU | Date28 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- V70 079456 0010 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 4 Mar 2024
- Expires
- 3 Mar 2029
Specification
- Model / Reference
- TR004.2-250IC
- Primary DI / UDI-DI
- 04049055003891
- Basic UDI-DI
- 40490550300001100TU
- EMDN Code
- W0105020216 Hepatitis b virus - na reagents
- Device Class
- Class D
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- DE-MF-000008606
Other devices from Hain Lifescience GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 50a8d40c-834c-41cc-8d83-8b51c86f9b1e