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Total Prostate Specific Antigen Determination Kit (Fluorescence Immunochromatog…
EUDAMEDClass C (EU MDR)
Ref P12201Model 25 tests/box
Identity
- Trade Name
- Total Prostate Specific Antigen Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Total Prostate Specific Antigen Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP12201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580415 EUDAMED
- Basic UDI-DI
- 697518250P122015V EUDAMED
- Direct Marketing DI
- 06942293580415 EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
New Device
Yes
EUDAMED
Total Prostate Specific Antigen Determination Kit (Fluorescence Immunochromatog… by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P122015V | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4c048af9-271c-4a97-b706-0b51815baca5 61 fields · synced Jun 19, 2026