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Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref 3021079Model 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kitRef 3013859Model 1×50 Tests/kitRef 3008728Model 1×100 Tests/kit
Identity
- Trade Name
- Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit EUDAMED3021079 EUDAMED1×50 Tests/kit EUDAMED3013859 EUDAMED1×100 Tests/kit EUDAMED3008728 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794589460 EUDAMED06925794519702 EUDAMED06925794511775 EUDAMED
- Basic UDI-DI
- 69257945W01020401R0XW EUDAMEDB-06925794519702 EUDAMEDB-06925794511775 EUDAMED
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass 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
New Device
No
EUDAMED
Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class B — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69257945W01020401R0XW | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69257945W01020401R0XW | Class B | 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 c96fd6eb-2b62-47a1-8e10-9841d2832402 61 fields · synced Jul 17, 2026
- EUDAMED 11dbe77f-fa96-44f6-889e-c066c9fada03 61 fields · synced May 18, 2026
- EUDAMED a12293eb-9a62-42ae-b859-82f73aee6192 61 fields · synced May 18, 2026