← Back to catalogue
Cancer Antigen 125 Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass C (EU MDR)
Ref P12205Model 25 tests/box
Identity
- Trade Name
- Cancer Antigen 125 Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Cancer Antigen 125 Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP12205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580156 EUDAMED
- Basic UDI-DI
- 697518250P1220565 EUDAMED
- Direct Marketing DI
- 06942293580156 EUDAMED
- EMDN Code
- W0102030106 CANCER ANTIGEN 125 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 125 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 | 697518250P1220565 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 531c1356-7ab6-41a8-a4a5-32ac2d427792 61 fields · synced Jun 18, 2026