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Free Thyroxine Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2020E-150Ref S2020E-200Ref S2020E-25Ref S2020E-75
Identity
- Device Name
- Free Thyroxine Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2020E-150 EUDAMEDS2020E-200 EUDAMEDS2020E-25 EUDAMEDS2020E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737464 EUDAMED06955792737471 EUDAMED06955792737426 EUDAMED06955792737440 EUDAMED
- Basic UDI-DI
- B-06955792737464 EUDAMEDB-06955792737471 EUDAMEDB-06955792737426 EUDAMEDB-06955792737440 EUDAMED
- EMDN Code
- W01020402 FREE THYROXINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Free Thyroxine Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06955792737464 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED debd71a2-5709-4e7d-8455-5a72fca7dcfe 61 fields · synced Jul 25, 2026
- EUDAMED 3369e899-8972-4469-a2a0-5ff173cd10f6 61 fields · synced May 18, 2026
- EUDAMED e9f2bdbd-c2eb-4a43-8d0c-e9e3e04c5b94 61 fields · synced May 18, 2026
- EUDAMED 2f551cc3-ac27-4a19-bc13-e03de77caa5d 61 fields · synced May 18, 2026