BC60-360
by Autobio Labtec Instruments Co., Ltd. China EUDAMED
Ref 05119Model BC60, BC60 Se,BC60-120, BC60-180,BC60-240,BC60-300,BC60-360
EMDN W02030201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697304909Model62UL | Date30 Sep 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Microbial Detection System
- Model / Reference
- BC60, BC60 Se,BC60-120, BC60-180,BC60-240,BC60-300,BC60-360, 05119
- Primary DI / UDI-DI
- 06973049097086
- Basic UDI-DI
- 697304909Model62UL
- EMDN Code
- W02030201 Automated blood culture analysers
- Device Class
- Class A
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000012110
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Autobio Labtec Instruments Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
Sources (1)
- EUDAMED 06973049097086|697304909MODEL62UL