Automated Blood Culture System
by Taho Future ( Tianjin ) Biotechnology Co., Ltd 3 variants
Ref TaiCube 120
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697650495BCS01K2 06976504951022 | Date15 May 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- TaiCube 120
- Primary DI / UDI-DI
- 06976504951022
- Basic UDI-DI
- 697650495BCS01K2
- Direct Marketing DI
- 06976504951022
- EMDN Code
- W02030201 Automated blood culture analysers
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000037788
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Taho Future ( Tianjin ) Biotechnology Co., Ltd
See all devices from Taho Future ( Tianjin ) Biotechnology Co., Ltd →
Properties
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