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Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref 3021065Model 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
- 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit EUDAMED3021065 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794589477 EUDAMED
- Basic UDI-DI
- 69257945W01020401R0XW EUDAMED
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class 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 B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 810c9144-873e-4e6b-8942-07d98227379c 61 fields · synced Jun 18, 2026