SepsiBiyo
by Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Ltd. Şti̇. Türkiye EUDAMED
Ref ML 105 EMDN W0104010504
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number86852392493ML105BV | Date18 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Myco/F Lytic Blood Culture Bottle
- Model / Reference
- ML 105
- Primary DI / UDI-DI
- 08685239249370
- Basic UDI-DI
- 86852392493ML105BV
- Direct Marketing DI
- 08685239249370
- 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 393904c0-59c7-4c2d-ba1f-5c3e0213506b