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Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013860Model 2×50 Tests/kitModel 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit
Identity
- Trade Name
- Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 Tests/kit EUDAMED3013860 EUDAMED1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794588449 EUDAMED
- Basic UDI-DI
- B-06925794588449 EUDAMED69257945W01020401R0XW EUDAMED
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B 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 IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06925794588449 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06925794588449 | 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 (2)
- EUDAMED b61a503a-0e91-4a4d-a82f-2a35efde7665 61 fields · synced Aug 4, 2026
- EUDAMED 45280ee0-98a8-4e7c-9715-867e4222ed93 61 fields · synced May 17, 2026