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Human anti-parotid secretory protein antibody CLIA Kit (IgM)
EUDAMEDClass IVD General (EU MDR)
Ref CK-2484-100M
Identity
- Device Name
- Human anti-parotid secretory protein antibody CLIA Kit (IgM) EUDAMED
- Model / Reference
- CK-2484-100M EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CK-2484-100M8C EUDAMED
- Basic UDI-DI
- B-CK-2484-100M8C EUDAMED
- EMDN Code
- W0102100199 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
No
EUDAMED
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-parotid secretory protein antibody CLIA Kit (IgM) by Guangzhou Kangrun Biotech Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-CK-2484-100M8C | 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 (1)
- EUDAMED a51207a6-23ad-47a5-8ae2-41412050fbea 61 fields · synced Oct 6, 2026