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Finecare™ PSA Control
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref W814-L, W814-M, W814-H
Identity
- Device Name
- Finecare™ PSA Control EUDAMED
- Model / Reference
- W814-L, W814-M, W814-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-W814JU EUDAMED
- Basic UDI-DI
- B-W814JU EUDAMED
- EMDN Code
- W0102152005 TUMOUR MARKER CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Finecare™ PSA Control by Guangzhou Wondfo Biotech Co., Ltd. — Class IVD Annex II List B — 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-W814JU | Class IVD Annex II List B | 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 (2)
- EUDAMED 78dc18c5-77b9-4b24-9f64-10bb3d8ae4c2 61 fields · synced Oct 6, 2026
- EUDAMED 78dc18c5-77b9-4b24-9f64-10bb3d8ae4c2-1 61 fields · synced Jun 10, 2026