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Platelet Aggregation COL Kit
EUDAMEDClass IVD General (EU MDR)
Ref HE50148Model 0.5mL×1
Identity
- Device Name
- Platelet Aggregation COL Kit EUDAMED
- Model / Reference
- 0.5mL×1 EUDAMEDHE50148 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975838807715 EUDAMED
- Basic UDI-DI
- B-06975838807715 EUDAMED
- EMDN Code
- W0103020199 GENERAL COAGULATION TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Platelet Aggregation COL Kit by Zhejiang Pushkang Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975838807715 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000042656
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED d0892e69-92b3-473a-87ee-2c6d655a398e 61 fields · synced Jun 11, 2026