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One Step Prostate Specific Antigen (PSA) Serum/Plasma Test
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref W31-S
Identity
- Device Name
- One Step Prostate Specific Antigen (PSA) Serum/Plasma Test EUDAMED
- Model / Reference
- W31-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-W31-SV5 EUDAMED
- Basic UDI-DI
- B-W31-SV5 EUDAMED
- EMDN Code
- W0102160202 PSA - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
One Step Prostate Specific Antigen (PSA) Serum/Plasma Test by Guangzhou Wondfo Biotech Co., Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED
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-W31-SV5 | 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 (1)
- EUDAMED b3bceb08-b2f0-4137-ab3b-51c3a93c2228 61 fields · synced Jul 9, 2026