SepsiBiyo
by Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Ltd. Şti̇. Türkiye EUDAMED
Ref SB 101
EMDN W0104010504
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number86852392493SB101BH | Date18 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Anaerobic Blood Culture Bottle
- Model / Reference
- SB 101
- Primary DI / UDI-DI
- 08685239249318
- Basic UDI-DI
- 86852392493SB101BH
- Direct Marketing DI
- 08685239249318
- EMDN Code
- W0104010504 Bottles for automated blood culture
- 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
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED d20dbe56-1047-441c-87d2-1ece9d8b6439