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Rheumatoid Factor Assay Kit (Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 20TRef DL191505Model 50tests/kit
Identity
- Trade Name
- Rheumatoid Factor Assay Kit (Fluorescence Immunoassay) EUDAMED
- Device Name
- Rheumatoid Factor Assay Kit (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- 20T EUDAMED50tests/kit EUDAMEDDL191505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424221383 EUDAMED06975424223714 EUDAMED
- Basic UDI-DI
- B-06975424221383 EUDAMEDB-06975424223714 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS 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 Assay Kit (Fluorescence Immunoassay) by DiYaLab ZJG Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06975424221383 | 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 ac3d73c8-4977-40a8-8e7e-129dc6a6745f 61 fields · synced Jul 8, 2026
- EUDAMED 19bab035-c72e-4534-882e-00448647b0a2 61 fields · synced May 17, 2026