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Total Thyroxine Kit (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 690047Model 100TRef 690046Model 50T 2×50T 100T 2×100T
Identity
- Trade Name
- Total Thyroxine Kit (Electrochemiluminescence Immunoassay) EUDAMEDTotal Thyroxine Kit（Electrochemiluminescence Immunoassay） EUDAMED
- Device Name
- Total Thyroxine Kit (Electrochemiluminescence Immunoassay) EUDAMEDTotal Thyroxine Kit（Electrochemiluminescence Immunoassay） EUDAMED
- Model / Reference
- 100T EUDAMED690047 EUDAMED50T 2×50T 100T 2×100T EUDAMED690046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689421 EUDAMED
- Basic UDI-DI
- B-06970341689421 EUDAMED69703416803205010HW EUDAMED
- EMDN Code
- W01020407 THYROXINE 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 Thyroxine Kit (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology 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-06970341689421 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341689421 | 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 c91cb372-78af-49bc-a04c-1b2c3f003807 61 fields · synced Jul 16, 2026
- EUDAMED 0bf126e7-77f5-4d5f-b5a9-6f2bfd75aa9c 61 fields · synced May 19, 2026