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CoaguDx Quality Control
EUDAMEDClass IVD General (EU MDR)
Ref W-CL1-QC-3Model Level 1：3 vial×1 mL Level 2：3 vial×1 mL
Identity
- Trade Name
- CoaguDx Quality Control EUDAMED
- Device Name
- CoaguDx Quality Control EUDAMED
- Model / Reference
- Level 1：3 vial×1 mL Level 2：3 vial×1 mL EUDAMEDW-CL1-QC-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896413638 EUDAMED
- Basic UDI-DI
- B-06978896413638 EUDAMED
- EMDN Code
- W0103020799 HAEMOSTASIS CONTROLS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
CoaguDx Quality Control by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06978896413638 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 89a2ed4d-3130-446d-b7d3-ca79f6433698 61 fields · synced Oct 7, 2026