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Total Triiodothyronine Kit (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 690048Model 50TModel 50T 2×50T 100T 2×100T
Identity
- Trade Name
- Total Triiodothyronine Kit (Electrochemiluminescence Immunoassay) EUDAMEDTotal Triiodothyronine Kit（Electrochemiluminescence Immunoassay EUDAMED
- Device Name
- Total Triiodothyronine Kit (Electrochemiluminescence Immunoassay) EUDAMEDTotal Triiodothyronine Kit（Electrochemiluminescence Immunoassay） EUDAMED
- Model / Reference
- 50T EUDAMED690048 EUDAMED50T 2×50T 100T 2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689391 EUDAMED
- Basic UDI-DI
- B-06970341689391 EUDAMED69703416803205011HY EUDAMED
- EMDN Code
- W01020405 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
Total 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-06970341689391 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341689391 | 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 b00fc8ae-5174-4d18-9262-48336c3c0bce 61 fields · synced Jul 9, 2026
- EUDAMED 9ba668ff-709c-49f8-ba51-6977831c5b99 61 fields · synced May 19, 2026