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ACT CoaguDx Test Strip
EUDAMEDClass IVD General (EU MDR)
Ref W-CL1-ACT-12Model 12 Strips / KitRef W-CL1-ACT-06Model 6 Strips / KitRef W-CL1-ACT-24Model 24 Strips / Kit
Identity
- Trade Name
- ACT CoaguDx Test Strip EUDAMED
- Device Name
- ACT CoaguDx Test Strip EUDAMED
- Model / Reference
- 12 Strips / Kit EUDAMEDW-CL1-ACT-12 EUDAMED6 Strips / Kit EUDAMEDW-CL1-ACT-06 EUDAMED24 Strips / Kit EUDAMEDW-CL1-ACT-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896413669 EUDAMED06978896413652 EUDAMED06978896413676 EUDAMED
- Basic UDI-DI
- B-06978896413669 EUDAMEDB-06978896413652 EUDAMEDB-06978896413676 EUDAMED
- EMDN Code
- W0103020104 ACTIVATED CLOTTING TIME 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
ACT CoaguDx Test Strip by Wuhan Easydiagnosis Biomedicine 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-06978896413669 | 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 (3)
- EUDAMED 0fb515fa-b33f-4844-b9bf-bdb836ba6254 61 fields · synced Oct 6, 2026
- EUDAMED ea0a2512-8b34-4104-af16-5bb9ff110c64 61 fields · synced May 17, 2026
- EUDAMED 09b77586-991e-4681-8ccf-b7cc328519e4 61 fields · synced May 18, 2026