Gram Positive bacteria AST (MALDI-TOF MS)
by Autobio Diagnostics Co., Ltd. China EUDAMED
Ref MS0201Model Automated Mass Spectrometry Microbial Identification System（Autof） EMDN W0104080110
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697015090000366HV | Date14 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Automated Mass Spectrometry Microbial Identification System（Autof）, MS0201
- Primary DI / UDI-DI
- 06942359511179
- Basic UDI-DI
- 697015090000366HV
- EMDN Code
- W0104080110 Combined susceptibility and identification systems gram positives - automated
- Device Class
- Class C
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000003348
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Autobio Diagnostics 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
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06942359511179|697015090000366HV