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Human anti-CA6 antibody CLIA Kit (IgA)
EUDAMEDClass IVD General (EU MDR)
Ref CJZ-K-2485-ARef CK-2485-100A
Identity
- Device Name
- Human anti-CA6 antibody CLIA Kit (IgA) EUDAMED
- Model / Reference
- CJZ-K-2485-A EUDAMEDCK-2485-100A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CJZ-K-2485-AMU EUDAMEDD-CK-2485-100A7Z EUDAMED
- Basic UDI-DI
- B-CJZ-K-2485-AMU EUDAMEDB-CK-2485-100A7Z 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 (IgA) 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-AMU | 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 (2)
- EUDAMED de9cfb07-2121-4d55-9fea-489fd23a8624 61 fields · synced Jul 24, 2026
- EUDAMED 7d0b30e0-0660-49bd-8552-6e3fb2640fc4 61 fields · synced May 17, 2026