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GADA CLIA Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100 tests/kitRef CL30152ENRef CL30152EModel 100tests/kit
Identity
- Trade Name
- GADA CLIA Assay Kit EUDAMED
- Device Name
- GADA CLIA Assay Kit EUDAMED
- Model / Reference
- 100 tests/kit EUDAMEDCL30152EN EUDAMED100tests/kit EUDAMEDCL30152E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424222113 EUDAMED06975424224087 EUDAMED06975424222625 EUDAMED
- Basic UDI-DI
- B-06975424222113 EUDAMEDB-06975424224087 EUDAMEDB-06975424222625 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
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
GADA 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-06975424222113 | 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 (3)
- EUDAMED 0377cb1f-7d0d-445b-af9a-5f6468cef669 61 fields · synced Oct 7, 2026
- EUDAMED 2aff2d0b-810d-477a-a9ef-fff8fb214076 61 fields · synced Jul 8, 2026
- EUDAMED 5277aa63-1325-4ccd-afa2-7e36872ca18b 61 fields · synced Jul 12, 2026