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Free Thyroxine Kit (Electrochemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref 690054Model 50T 2×50T 100T 2×100TModel 100T
Identity
- Trade Name
- Free Thyroxine Kit (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Free Thyroxine Kit (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50T 2×50T 100T 2×100T EUDAMED690054 EUDAMED100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341685935 EUDAMED
- Basic UDI-DI
- 69703416803205012J2 EUDAMEDB-06970341685935 EUDAMED
- EMDN Code
- W01020402 FREE THYROXINE EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General 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 B — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69703416803205012J2 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205012J2 | Class B | 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 278b5da4-4082-4dbc-b910-ead92c163b99 61 fields · synced Jul 30, 2026
- EUDAMED ae52e6b8-1715-4728-a15a-6ca69b05a3fd 61 fields · synced May 19, 2026