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Wondfo Optical Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref W958Model OCG-102
Identity
- Trade Name
- Wondfo Optical Coagulation Analyzer EUDAMED
- Device Name
- Optical Coagulation Analyzer EUDAMED
- Model / Reference
- OCG-102 EUDAMEDW958 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933289811149 EUDAMED
- Basic UDI-DI
- 69332898CE1114EP EUDAMED
- Direct Marketing DI
- 06933289811149 EUDAMED
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Wondfo Optical Coagulation Analyzer by Guangzhou Wondfo Biotech Co., Ltd. — Class A — IVDR — 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 | 69332898CE1114EP | Class A | 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 05c9e939-f0b6-439f-82d4-9e323ebfd39c 61 fields · synced Jul 16, 2026