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Free Prostate Specific Antigen (fPSA) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/Kit
Identity
- Trade Name
- Free Prostate Specific Antigen (fPSA) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Free Prostate Specific Antigen (fPSA) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 100 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813449 EUDAMED
- Basic UDI-DI
- B-06974986813449 EUDAMED
- EMDN Code
- W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Free Prostate Specific Antigen (fPSA) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…
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-06974986813449 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 41a0218d-bf52-4b8e-a3ea-b7c6ceb871b6 61 fields · synced Oct 6, 2026