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Diagnostic Kit for ANA (IFA)
EUDAMEDClass IVD General (EU MDR)
Ref CK-2201-120GRef CK-2201-060G
Identity
- Device Name
- Diagnostic Kit for ANA (IFA) EUDAMED
- Model / Reference
- CK-2201-120G EUDAMEDCK-2201-060G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926980312343 EUDAMED06926980312336 EUDAMED
- Basic UDI-DI
- B-06926980312343 EUDAMEDB-06926980312336 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Diagnostic Kit for ANA (IFA) 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-06926980312343 | 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 1f60eaec-7347-402d-ab25-4f8aa1e4c2f4 61 fields · synced Sep 17, 2026
- EUDAMED 083d51d3-2766-424f-9c31-b66cf81cbf98 61 fields · synced May 19, 2026