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Thyroxine Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013827Model 1×50 Tests/kitRef 3008740Model 1×100 Tests/kitRef 3013872Model 2×50 Tests/kit
Identity
- Trade Name
- Thyroxine Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Thyroxine Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×50 Tests/kit EUDAMED3013827 EUDAMED1×100 Tests/kit EUDAMED3008740 EUDAMED2×50 Tests/kit EUDAMED3013872 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794523440 EUDAMED06925794511812 EUDAMED06942202223907 EUDAMED
- Basic UDI-DI
- B-06925794523440 EUDAMEDB-06925794511812 EUDAMEDB-06942202223907 EUDAMED
- EMDN Code
- W01020407 THYROXINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Thyroxine Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial 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-06925794523440 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED b78c395d-0954-4987-beff-ad64bc2cf168 61 fields · synced Jul 29, 2026
- EUDAMED 8002fb8c-a39f-4d78-86a0-3e328c762a12 61 fields · synced May 16, 2026
- EUDAMED e9286f19-df11-4b44-8fca-4a2dc4607453 61 fields · synced May 18, 2026