Thrombin Time
by Wiener Laboratorios SAIC Argentina EUDAMED
Ref 42010
EMDN W0103020103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-07791778046286 | Date4 May 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Tiempo de Trombina
- Model / Reference
- 42010
- Primary DI / UDI-DI
- 07791778046286
- Basic UDI-DI
- B-07791778046286
- EMDN Code
- W0103020103 Thrombin time / reptilase / batroxobin time
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- AR-MF-000023605
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Wiener Laboratorios SAIC
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 6da2bdc7-7f3b-402a-8f96-cde977180fdb