SepsiBiyo
by Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Ltd. Şti̇. EUDAMED
Active
Ref SB 60Model Modular 60
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number86852392493SB609G | 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- Withdrawn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 60, SB 60
- Primary DI / UDI-DI
- 08685239249332
- Basic UDI-DI
- 86852392493SB609G
- Direct Marketing DI
- 08685239249332
- 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
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