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Human anti-CA6 antibody CLIA Kit (IgM)
EUDAMEDClass IVD General (EU MDR)
Ref CJZ-K-2485-MRef CK-2485-100MRef CK-2485-050M
Identity
- Device Name
- Human anti-CA6 antibody CLIA Kit (IgM) EUDAMED
- Model / Reference
- CJZ-K-2485-M EUDAMEDCK-2485-100M EUDAMEDCK-2485-050M EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CJZ-K-2485-MNL EUDAMEDD-CK-2485-100M8R EUDAMEDD-CK-2485-050M9B EUDAMED
- Basic UDI-DI
- B-CJZ-K-2485-MNL EUDAMEDB-CK-2485-100M8R EUDAMEDB-CK-2485-050M9B EUDAMED
- EMDN Code
- W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMEDW0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
Animal Tissues
Yes
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
Human anti-CA6 antibody CLIA Kit (IgM) by Guangzhou Kangrun Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-CJZ-K-2485-MNL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Kangrun Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000032267
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED 904b128f-d867-4973-8575-386788c07285 61 fields · synced Jul 27, 2026
- EUDAMED bd92ee54-f866-495f-aa9e-f1352be9e033 61 fields · synced May 17, 2026
- EUDAMED 3fa2d28e-1583-4cbb-8391-c1882515616a 61 fields · synced May 17, 2026