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Cancer Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Microparticle Immunoas…
EUDAMEDClass IVD General (EU MDR)
Ref "REF: USIA00000133M, USIA00000134M"
Identity
- Device Name
- Cancer Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Microparticle Immunoassay) EUDAMED
- Model / Reference
- "REF: USIA00000133M, USIA00000134M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-81AL EUDAMED
- Basic UDI-DI
- B-6-81AL EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 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 19-9 (CA19-9) Assay Kit (Chemiluminescent Microparticle Immunoas… 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-6-81AL | 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 9179f305-8db4-474a-b9ae-e40472b1754f-1 61 fields · synced Oct 6, 2026
- EUDAMED 9179f305-8db4-474a-b9ae-e40472b1754f-2 61 fields · synced Jul 28, 2026