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Prostate Specific Antigen (PSA) Rapid Test Strip (Whole blood +2 more)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref GEPSA-401a
Identity
- Trade Name
- Prostate Specific Antigen (PSA) Rapid Test Strip (Whole blood/Serum/Plasma) EUDAMEDProstate Specific Antigen (PSA) Rapid Test Strip (Whole Blood /Serum/Plasma) EUDAMED
- Device Name
- Prostate Specific Antigen (PSA) Rapid Test EUDAMED
- Model / Reference
- GEPSA-401a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GEPSA-401a6Q EUDAMEDD-GEPSA-401aHG7Y EUDAMED
- Basic UDI-DI
- B-GEPSA-401a6Q EUDAMEDB-GEPSA-401aHG7Y EUDAMED
- EMDN Code
- W0102160202 PSA - RT & POC EUDAMED
- Models / Variants
- Whole blood EUDAMEDSerum EUDAMEDPlasma 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prostate Specific Antigen (PSA) Rapid Test Strip (Whole blood +2 more) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD Annex II List B — IVDD — listed in…
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-GEPSA-401a6Q | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 8455c8e5-3944-47c4-aca3-6b8079bfd36a 61 fields · synced Oct 7, 2026
- EUDAMED 143a19c3-f46f-4c1d-8741-b754de85e203 61 fields · synced Oct 7, 2026