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Free Triiodothyronine Kit (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 690059Model 2×100TModel 50T 2×50T 100T 2×100T
Identity
- Trade Name
- Free Triiodothyronine Kit (Electrochemiluminescence Immunoassay) EUDAMEDFree Triiodothyronine Kit（Electrochemiluminescence Immunoassay） EUDAMED
- Device Name
- Free Triiodothyronine Kit (Electrochemiluminescence Immunoassay) EUDAMEDFree Triiodothyronine Kit（Electrochemiluminescence Immunoassay） EUDAMED
- Model / Reference
- 2×100T EUDAMED690059 EUDAMED50T 2×50T 100T 2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341680947 EUDAMED
- Basic UDI-DI
- B-06970341680947 EUDAMED69703416803205013J4 EUDAMED
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany 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 Kit (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in…
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-06970341680947 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341680947 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED a9c4e494-d40d-456a-87c2-aef69696193f 61 fields · synced Jul 24, 2026
- EUDAMED 95278e0e-c4de-4fcb-88d0-8a4c9e5157f1 61 fields · synced May 19, 2026