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PT/APTT CoaguDx Dual Test Strip
EUDAMEDClass IVD General (EU MDR)
Ref W-CL1-P&A-SC-96Model 96 Strips / Kit (Note: One-step method)
Identity
- Trade Name
- PT/APTT CoaguDx Dual Test Strip EUDAMED
- Device Name
- PT/APTT CoaguDx Dual Test Strip EUDAMED
- Model / Reference
- 96 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-P&A-SC-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896413836 EUDAMED
- Basic UDI-DI
- B-06978896413836 EUDAMED
- EMDN Code
- W0103020199 GENERAL COAGULATION TESTS - 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
PT/APTT CoaguDx Dual Test Strip 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-06978896413836 | 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 97985bc7-2895-4ade-a1b1-d91bcaef725b 61 fields · synced Oct 6, 2026