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Cancer Antigen 50 (CA50) Assay Kit (Chemiluminescent Microparticle Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref "REF: USIA00000137M, USIA00000138M"
Identity
- Device Name
- Cancer Antigen 50 (CA50) Assay Kit (Chemiluminescent Microparticle Immunoassay) EUDAMED
- Model / Reference
- "REF: USIA00000137M, USIA00000138M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-75AR EUDAMED
- Basic UDI-DI
- B-6-75AR EUDAMED
- EMDN Code
- W0102030104 CANCER ANTIGEN 50 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 50 (CA50) Assay Kit (Chemiluminescent Microparticle Immunoassay) by URIT Medical Electronic 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-6-75AR | Class IVD General | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 61a18c5e-26a5-40b8-be8d-4b0ca05524e5-1 61 fields · synced Oct 6, 2026
- EUDAMED 61a18c5e-26a5-40b8-be8d-4b0ca05524e5-2 61 fields · synced Jul 14, 2026