Automated Rapid AST System
by Taho Future ( Tianjin ) Biotechnology Co., Ltd China EUDAMED
Ref Fast Check
EMDN W02030199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697650495AST01NC | Date10 Jul 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Fast Check
- Primary DI / UDI-DI
- 06976504950001
- Basic UDI-DI
- 697650495AST01NC
- Direct Marketing DI
- 06976504950001
- EMDN Code
- W02030199 Antibiotic susceptibility analysers - other
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000037788
- Authorised representative
- MedPath GmbH DE-AR-000000087
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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 6727b70a-5b7b-475b-b93d-2098d7fbbbaa