Thrombelastograph Hemostasis Analyzer
by Pro-med (Beijing) Technology Co., Ltd. China EUDAMED
Ref ST-1000
EMDN W0202029001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697547451WTST-10005U | Date13 Nov 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Thrombelastograph Hemostasis Analyzer
- Model / Reference
- ST-1000
- Primary DI / UDI-DI
- 06975474519652
- Basic UDI-DI
- 697547451WTST-10005U
- EMDN Code
- W0202029001 Thrombelastographs
- Device Class
- Class A
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000027394
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 766166b8-64ed-4169-88d6-3328fe590e5a