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Free T4 CLIA Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100 tests/kitRef CL31062EN
Identity
- Trade Name
- Free T4 CLIA Assay Kit EUDAMEDIgG4 CLIA Assay Kit EUDAMEDFree T3 CLIA Assay Kit EUDAMED
- Device Name
- Free T4 CLIA Assay Kit EUDAMEDIgG4 CLIA Assay Kit EUDAMEDFree T3 CLlA Assay Kit EUDAMED
- Model / Reference
- 100 tests/kit EUDAMEDCL31062EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424222441 EUDAMED06975424222458 EUDAMED06975424224360 EUDAMED
- Basic UDI-DI
- B-06975424222441 EUDAMEDB-06975424222458 EUDAMEDB-06975424224360 EUDAMED
- EMDN Code
- W01020402 FREE THYROXINE EUDAMEDW0102019099 SPECIFIC PROTEINS - 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
Free T4 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-06975424222441 | 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 (5)
- EUDAMED e5ec22c1-044b-4019-a021-24be2f55eb11 61 fields · synced Oct 6, 2026
- EUDAMED c082b2a3-7ed4-4778-b937-c08362838133 61 fields · synced May 19, 2026
- EUDAMED a1cc8516-e913-479c-9bfa-5acbbb1bb1a2 61 fields · synced Jun 18, 2026
- EUDAMED 87b215f4-1b80-4441-92bb-1160be1e9382 61 fields · synced Jul 8, 2026
- EUDAMED 248fdd49-0796-4aba-b817-a6a1f395390c 61 fields · synced Jul 23, 2026