Identity
- Trade Name
- T4 CLIA Assay Kit EUDAMEDT3 CLIA Assay Kit EUDAMED
- Device Name
- T4 CLIA Assay Kit EUDAMED
- Model / Reference
- 100 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424222410 EUDAMED
- Basic UDI-DI
- B-06975424222410 EUDAMED
- EMDN Code
- W01020406 T- UPTAKE 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
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-06975424222410 | 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 87f72c9f-d7d7-4d0d-aa70-aa3f0a0f902b 61 fields · synced Oct 7, 2026
- EUDAMED a13e6460-4445-4330-b594-22b1b483f2e6 61 fields · synced Jun 18, 2026