TEClot PT-S
by TECO Medical Instruments, Production + Trading GmbH Germany EUDAMED
Ref A0230-010
EMDN W0103020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-PTS-A0230-010WW | Date21 Aug 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- PT-S (Quick)
- Model / Reference
- A0230-010
- Primary DI / UDI-DI
- D-PTS-A0230-010WW
- Basic UDI-DI
- B-PTS-A0230-010WW
- EMDN Code
- W0103020101 Prothrombin time ( quick test )
- 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 (1)
- EUDAMED 8e616d80-b9ef-44b4-8695-c191fbab4b82