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Total prostate specific antigen CLIA Kit (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref F12214Model 100 tests/box
Identity
- Trade Name
- Total prostate specific antigen CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Total prostate specific antigen CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF12214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590278 EUDAMED
- Basic UDI-DI
- 697518250F1221424 EUDAMED
- Direct Marketing DI
- 06942293590278 EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
Total prostate specific antigen CLIA Kit (Chemiluminescence Immunoassay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED
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 | 697518250F1221424 | 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 3e78a3cc-4383-4257-b995-5f87489a34eb 61 fields · synced Jun 19, 2026