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TSH CLIA Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100 tests/kitRef CL21012EN
Identity
- Trade Name
- TSH CLIA Assay Kit EUDAMEDT4 CLIA Assay Kit EUDAMED
- Device Name
- TSH CLIA Assay Kit EUDAMEDT4 CLIA Assay Kit EUDAMED
- Model / Reference
- 100 tests/kit EUDAMEDCL21012EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424222427 EUDAMED06975424226876 EUDAMED
- Basic UDI-DI
- B-06975424222427 EUDAMEDB-06975424226876 EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE 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
TSH 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-06975424222427 | 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 d5b428ce-c1c3-44ca-a884-7be4fde0c6d0 61 fields · synced Oct 6, 2026
- EUDAMED cb56465a-b3c0-4f2b-81c8-fe1a75b7fe33 61 fields · synced Jun 18, 2026
- EUDAMED 12c3c9bf-711f-4c10-976d-d8dc3f90d037 61 fields · synced Aug 1, 2026