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Rheumatoid Factor IgA CLIA Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100 tests/kitRef CL30572EN
Identity
- Trade Name
- Rheumatoid Factor IgA CLIA Assay Kit EUDAMED
- Device Name
- Rheumatoid Factor IgA CLIA Assay Kit EUDAMED
- Model / Reference
- 100 tests/kit EUDAMEDCL30572EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424222380 EUDAMED06975424224186 EUDAMED
- Basic UDI-DI
- B-06975424222380 EUDAMEDB-06975424224186 EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - 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
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
Rheumatoid Factor IgA 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-06975424222380 | 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 9b75f16f-33c5-4c95-a176-58bb5f3f0688 61 fields · synced Jul 11, 2026
- EUDAMED c0f4e52d-3b20-4c08-b835-de0c022f05e3 61 fields · synced Jul 8, 2026