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Free Thyroxine Kit (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 690053Model 2×50TModel 50T 2×50T 100T 2×100T
Identity
- Trade Name
- Free Thyroxine Kit (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Free Thyroxine Kit (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50T EUDAMED690053 EUDAMED50T 2×50T 100T 2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063072 EUDAMED
- Basic UDI-DI
- B-06975984063072 EUDAMED69703416803205012J2 EUDAMED
- EMDN Code
- W01020402 FREE 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
Free 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-06975984063072 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975984063072 | 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 0f6f3c38-e28c-46ed-90e9-3855f68adc2b 61 fields · synced Jul 24, 2026
- EUDAMED ec00ad72-a6d5-47a7-8b4c-7b8e32b7454d 61 fields · synced May 17, 2026