Autof ms800
by Autobio Labtec Instruments Co., Ltd. China EUDAMED
Ref 01104Model Autof ms800
EMDN W020303
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697304909Model95V3 | Date25 Jul 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Automated Mass Spectrometry Microbial Identification System
- Model / Reference
- Autof ms800, 01104
- Primary DI / UDI-DI
- 06973049099035
- Basic UDI-DI
- 697304909Model95V3
- Direct Marketing DI
- 06973049099035
- EMDN Code
- W020303 Mass - spectrometry system
- Device Class
- Class C
- 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 (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 9c8d710b-285f-49e9-8f4c-cf6deb800d83