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Cancer Antigen 153 Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass C (EU MDR)
Ref P12206Model 25 tests/box
Identity
- Trade Name
- Cancer Antigen 153 Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Cancer Antigen 153 Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP12206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580163 EUDAMED
- Basic UDI-DI
- 697518250P1220667 EUDAMED
- Direct Marketing DI
- 06942293580163 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 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
Cancer Antigen 153 Determination Kit (Fluorescence Immunochromatographic Assay) 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 | 697518250P1220667 | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 2fb777cc-679b-464e-8e6f-ecb3658949d0 61 fields · synced Oct 6, 2026