TEClot PT-B
by TECO Medical Instruments, Production + Trading GmbH Germany EUDAMED
Ref A0260-050
EMDN W0103020801
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-PTB-A0260-050G2 | Date15 Aug 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- PT-B (Owren)
- Model / Reference
- A0260-050
- Primary DI / UDI-DI
- D-PTB-A0260-050G2
- Basic UDI-DI
- B-PTB-A0260-050G2
- EMDN Code
- W0103020801 Prothrombin time rt & poc
- 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 (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 93c4899c-e969-4045-9c34-d3684a5e57a2