SepsiBiyo
by Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Ltd. Şti̇. Türkiye EUDAMED
Ref SB 120Model Modular 120 EMDN W02030201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number86852392493SB120BM | Date18 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Fully Automatic Blood Culture Machine - Integrated
- Model / Reference
- Modular 120, SB 120
- Primary DI / UDI-DI
- 08685239249349
- Basic UDI-DI
- 86852392493SB120BM
- Direct Marketing DI
- 08685239249349
- EMDN Code
- W02030201 Automated blood culture analysers
- Device Class
- Class A
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000054086
Other devices from Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Ltd. Şti̇.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED cb022ee3-6b10-43eb-a904-0d4e3ec5fd85