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Human anti-CA6 antibody CLIA Kit (IgG)
EUDAMEDClass IVD General (EU MDR)
Ref CK-2485-050GRef CJZ-K-2485-GRef CK-2485-100G
Identity
- Device Name
- Human anti-CA6 antibody CLIA Kit (IgG) EUDAMED
- Model / Reference
- CK-2485-050G EUDAMEDCJZ-K-2485-G EUDAMEDCK-2485-100G EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CK-2485-050G8X EUDAMEDD-CJZ-K-2485-GN8 EUDAMEDD-CK-2485-100G8D EUDAMED
- Basic UDI-DI
- B-CK-2485-050G8X EUDAMEDB-CJZ-K-2485-GN8 EUDAMEDB-CK-2485-100G8D EUDAMED
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMEDW0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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 (IgG) 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-CK-2485-050G8X | 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 da0f1e56-f20a-4a3b-b19f-017c09c43fcf 61 fields · synced Oct 6, 2026
- EUDAMED a52ff579-6a88-4294-8926-7064492f2f3b 61 fields · synced May 16, 2026
- EUDAMED e07a7ad6-bdca-4a19-877f-ba694afcdfa6 61 fields · synced May 17, 2026