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Cancer Antigen 72-4 (CA72-4) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/KitRef 25 Tests/KitRef 100 tests/kitRef 50 Tests/KitRef "REF: USIA00000135M, USIA00000136M"
Identity
- Trade Name
- Cancer Antigen 72-4 (CA72-4) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Cancer Antigen 72-4 (CA72-4) Assay Kit (Chemiluminescent Immunoassay) EUDAMEDCancer Antigen 72-4 (CA72-4) Assay Kit (Chemiluminescent Microparticle Immunoassay) EUDAMED
- Model / Reference
- 100 Tests/Kit EUDAMED25 Tests/Kit EUDAMED50 Tests/Kit EUDAMED"REF: USIA00000135M, USIA00000136M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813302 EUDAMED06974986814361 EUDAMED06937287300629 EUDAMED06974986813296 EUDAMEDD-6-76AT EUDAMED
- Basic UDI-DI
- B-06974986813302 EUDAMEDB-06974986814361 EUDAMEDB-06937287300629 EUDAMEDB-06974986813296 EUDAMEDB-6-76AT EUDAMED
- EMDN Code
- W0102030105 CANCER ANTIGEN 72-4 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
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 72-4 (CA72-4) 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-06974986813302 | 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 (6)
- EUDAMED f3b61489-ffa1-493c-906f-02e9c233ec31 61 fields · synced Oct 6, 2026
- EUDAMED 56a6db89-be0e-4994-acb6-457f5947f18a 61 fields · synced May 17, 2026
- EUDAMED 79ca2ed1-43ce-457a-a62d-b93cf7a7e62d 61 fields · synced May 17, 2026
- EUDAMED a38f9083-c209-4d00-abab-e0763ae1c75e 61 fields · synced May 17, 2026
- EUDAMED 05a11eed-fdd0-49f1-8ec7-978f26663e99-1 61 fields · synced Jul 12, 2026
- EUDAMED 05a11eed-fdd0-49f1-8ec7-978f26663e99-2 61 fields · synced Jul 12, 2026