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Cancer Antigen 125 (CA125) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/KitRef 25 Tests/KitRef 100 Tests/Kit
Identity
- Trade Name
- Cancer Antigen 125 (CA125) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Cancer Antigen 125 (CA125) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 50 Tests/Kit EUDAMED25 Tests/Kit EUDAMED100 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813210 EUDAMED06974986814330 EUDAMED06974986813227 EUDAMED
- Basic UDI-DI
- B-06974986813210 EUDAMEDB-06974986814330 EUDAMEDB-06974986813227 EUDAMED
- EMDN Code
- W0102030106 CANCER ANTIGEN 125 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Cancer Antigen 125 (CA125) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974986813210 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED bd91a0a5-2dbc-40f3-a4ad-18d949d2b30d 61 fields · synced Oct 6, 2026
- EUDAMED b171d450-f319-4f41-9bf5-e99371d109ff 61 fields · synced May 18, 2026
- EUDAMED 4d274051-d2e5-472e-b590-c347df06c07b 61 fields · synced May 18, 2026