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Anti-Cardiolipin IgG CLIA Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100 tests/kitRef CL30022EModel 100tests/kit
Identity
- Trade Name
- Anti-Cardiolipin IgG CLIA Assay Kit EUDAMED
- Device Name
- Anti-Cardiolipin IgG CLIA Assay Kit EUDAMED
- Model / Reference
- 100 tests/kit EUDAMED100tests/kit EUDAMEDCL30022E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424222144 EUDAMED06975424222649 EUDAMED
- Basic UDI-DI
- B-06975424222144 EUDAMEDB-06975424222649 EUDAMED
- EMDN Code
- W0102100501 ANTI-CARDIOLIPIN ANTIBODIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Anti-Cardiolipin IgG CLIA Assay Kit by DiYaLab ZJG 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-06975424222144 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DiYaLab ZJG Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000048648
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 439e8c47-7046-415a-8b07-252824fad3cf 61 fields · synced Jul 24, 2026
- EUDAMED 43ea74b3-8c50-4e38-bc8c-0fc44553093f 61 fields · synced Jul 24, 2026