← Back to catalogue
PT CoaguDx Test Strip
EUDAMEDClass IVD General (EU MDR)
Ref W-CL1-PT-12Model 12 Strips / KitRef W-CL1-PT-SC-96Model 96 Strips / Kit (Note: One-step method)Ref W-CL1-PT-24Model 24 Strips / KitRef W-CL1-PT-SC-48Model 48 Strips / Kit (Note: One-step method)Ref W-CL1-PT-SC-06Model 6 Strips / Kit (Note: One-step method)Ref W-CL1-PT-48Model 48 Strips / KitRef W-CL1-PT-SC-12Model 12 Strips / Kit (Note: One-step method)
Identity
- Trade Name
- PT CoaguDx Test Strip EUDAMED
- Device Name
- PT CoaguDx Test Strip EUDAMED
- Model / Reference
- 12 Strips / Kit EUDAMEDW-CL1-PT-12 EUDAMED96 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-PT-SC-96 EUDAMED24 Strips / Kit EUDAMEDW-CL1-PT-24 EUDAMED48 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-PT-SC-48 EUDAMED6 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-PT-SC-06 EUDAMED48 Strips / Kit EUDAMEDW-CL1-PT-48 EUDAMED12 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-PT-SC-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896413546 EUDAMED06978896413782 EUDAMED06978896413553 EUDAMED06978896413775 EUDAMED06978896413744 EUDAMED06978896413560 EUDAMED06978896413751 EUDAMED
- Basic UDI-DI
- B-06978896413546 EUDAMEDB-06978896413782 EUDAMEDB-06978896413553 EUDAMEDB-06978896413775 EUDAMEDB-06978896413744 EUDAMEDB-06978896413560 EUDAMEDB-06978896413751 EUDAMED
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) 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 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-06978896413546 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (7)
- EUDAMED 2781ab7b-e134-41c5-a9d1-2a0a771998a6 61 fields · synced Oct 6, 2026
- EUDAMED f71f7dc1-57da-424c-86e1-1b286c4144dd 61 fields · synced May 18, 2026
- EUDAMED 9df34d5f-9a0c-4f7d-82b1-56437a4056f1 61 fields · synced May 18, 2026
- EUDAMED 2860c735-22b4-47f6-9437-20b76bc5e611 61 fields · synced May 18, 2026
- EUDAMED 5b18799e-a41f-4e66-812a-965d16be2a0b 61 fields · synced May 18, 2026
- EUDAMED de7ac59e-6e10-46b0-8e07-056e4aa3be59 61 fields · synced May 18, 2026
- EUDAMED 3386c656-a5ca-4ca7-ba62-5ce99c13df33 61 fields · synced May 19, 2026