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PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device (Whole …
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref TPS-U402
Identity
- Device Name
- PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- TPS-U402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TPS-U402U6 EUDAMED
- Basic UDI-DI
- B-TPS-U402U6 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device (Whole … by Abon Biopharm(Hangzhou) Co., Ltd — Class IVD Annex II List B — 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-TPS-U402U6 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Abon Biopharm(Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000009171
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 91726e3d-cc12-4b2e-8389-bb4eba8440fa 61 fields · synced Jun 19, 2026