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Prothrombin Time Reagent Kit (Clotting)
EUDAMEDClass IVD General (EU MDR)
Ref W480
Identity
- Device Name
- Prothrombin Time Reagent Kit (Clotting) EUDAMED
- Model / Reference
- W480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933289804356 EUDAMED
- Basic UDI-DI
- B-06933289804356 EUDAMED
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prothrombin Time Reagent Kit (Clotting) by Guangzhou Wondfo Biotech 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-06933289804356 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED fc30c399-f1b8-482e-805a-dede55725510 61 fields · synced Oct 6, 2026