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Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/KitModel 100 Tests/Kit.Ref 100 tests/kit
Identity
- Trade Name
- Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay) EUDAMEDCancer Antigen 15-3（CA15-3）Assay Kit（Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 100 Tests/Kit. EUDAMED100 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813265 EUDAMED06937287300407 EUDAMED
- Basic UDI-DI
- B-06974986813265 EUDAMEDB-06937287300407 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 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 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD — listed…
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-06974986813265 | 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 (2)
- EUDAMED b8af2c10-6ae0-44c7-9b0d-258c56721f0f 61 fields · synced Oct 6, 2026
- EUDAMED 6b7c239a-fb6a-4c82-8ad7-b6235e53fd96 61 fields · synced May 19, 2026