TEClot FIB
by TECO Medical Instruments, Production + Trading GmbH Germany EUDAMED
Ref A0511-050, A0511-020
EMDN W0103020201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-FIB-A0511-050NB | Date16 Aug 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Fib
- Model / Reference
- A0511-050, A0511-020
- Primary DI / UDI-DI
- D-FIB-A0511-050NB, D-FIB-A0511-020N2
- Basic UDI-DI
- B-FIB-A0511-050NB, B-FIB-A0511-020N2
- EMDN Code
- W0103020201 Fibrinogen assays (factor i)
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000022642
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (2)
- EUDAMED 54d243b5-81c9-4685-84ff-18b5ca8be52b
- EUDAMED D-FIB-A0511-020N2|B-FIB-A0511-020N2