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APTT CoaguDx Test Strip
EUDAMEDClass IVD General (EU MDR)
Ref W-CL1-APTT-SC-12Model 12 Strips / Kit (Note: One-step method)Ref W-CL1-APTT-SC-24Model 24 Strips / Kit (Note: One-step method)Ref W-CL1-APTT-06Model 6 Strips / KitRef W-CL1-APTT-12Model 12 Strips / KitRef W-CL1-APTT-SC-96Model 96 Strips / Kit (Note: One-step method)Ref W-CL1-APTT-SC-48Model 48 Strips / Kit (Note: One-step method)Ref W-CL1-APTT-48Model 48 Strips / Kit
Identity
- Trade Name
- APTT CoaguDx Test Strip EUDAMED
- Device Name
- APTT CoaguDx Test Strip EUDAMED
- Model / Reference
- 12 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-APTT-SC-12 EUDAMED24 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-APTT-SC-24 EUDAMED6 Strips / Kit EUDAMEDW-CL1-APTT-06 EUDAMED12 Strips / Kit EUDAMEDW-CL1-APTT-12 EUDAMED96 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-APTT-SC-96 EUDAMED48 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-APTT-SC-48 EUDAMED48 Strips / Kit EUDAMEDW-CL1-APTT-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896413706 EUDAMED06978896413713 EUDAMED06978896413492 EUDAMED06978896413508 EUDAMED06978896413737 EUDAMED06978896413720 EUDAMED06978896413522 EUDAMED
- Basic UDI-DI
- B-06978896413706 EUDAMEDB-06978896413713 EUDAMEDB-06978896413492 EUDAMEDB-06978896413508 EUDAMEDB-06978896413737 EUDAMEDB-06978896413720 EUDAMEDB-06978896413522 EUDAMED
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN 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
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
APTT 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-06978896413706 | 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 (7)
- EUDAMED 1a8c7f2c-012f-45e8-883d-0a9024295e7b 61 fields · synced Oct 6, 2026
- EUDAMED 6d61e7d4-86f5-41f3-a86b-5694e0962ff2 61 fields · synced May 16, 2026
- EUDAMED f99868db-2bd6-4365-92c0-0f5a0686cb62 61 fields · synced May 16, 2026
- EUDAMED 9fd41670-dd78-41e9-a6dd-495f5e8db904 61 fields · synced May 16, 2026
- EUDAMED 7ddda23e-398d-4e29-b177-6dd7bd1f0c9d 61 fields · synced May 16, 2026
- EUDAMED f826f61f-68b8-465c-8ee2-53d5f7676985 61 fields · synced May 18, 2026
- EUDAMED 12e7b777-d816-487f-bb9a-61464bc5f1d8 61 fields · synced May 19, 2026