Thrombelastograph General Cup Kit
by Pro-med (Beijing) Technology Co., Ltd. China EUDAMED
Ref 10 tests/kit
EMDN W0202029001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975474516750 | Date18 Nov 2024 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Thrombelastograph General Cup Kit
- Model / Reference
- 10 tests/kit
- Primary DI / UDI-DI
- 06975474516750
- Basic UDI-DI
- B-06975474516750
- EMDN Code
- W0202029001 Thrombelastographs
- Device Class
- Class IVD General
- Market of Registration
- Italy
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 (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 bd4ac202-0c1f-444b-801b-5a0e7eefb841