Anatolia Geneworks
by Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S. Türkiye EUDAMED
Ref ABHBQ1
EMDN W0105020216
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberITDA/00004/0v002 | Date7 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- ITDA/00004/0v002 Amended
Technical documentation EU IVDR
- Notified body
- QMD Services GmbH 2962
- Issued
- 7 Sep 2026
- Expires
- 17 May 2031
- Reason
- Other
Specification
- Device Name
- Bosphore HBV Quantification Kit
- Model / Reference
- ABHBQ1
- Primary DI / UDI-DI
- 08680018942039
- Basic UDI-DI
- 868001894PCRHPTHBVQT100D9
- Direct Marketing DI
- 08680018942039
- EMDN Code
- W0105020216 Hepatitis b virus - na reagents
- Device Class
- Class D
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- TR-MF-000022487
Other devices from Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 838feae1-1992-42a4-aa90-52142bbfcc8b