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Free Triiodothyronine Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2021E-50Ref S2021E-150Ref S2021E-100
Identity
- Device Name
- Free Triiodothyronine Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2021E-50 EUDAMEDS2021E-150 EUDAMEDS2021E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737488 EUDAMED06955792737525 EUDAMED06955792737518 EUDAMED
- Basic UDI-DI
- B-06955792737488 EUDAMEDB-06955792737525 EUDAMEDB-06955792737518 EUDAMED
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE 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 Triiodothyronine 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-06955792737488 | 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 (3)
- EUDAMED 60e137ca-dc51-4309-bb8c-3ca28d5c8c3b 61 fields · synced Aug 4, 2026
- EUDAMED 6bdb2120-bf36-4eb9-ac63-ee280230cb5d 61 fields · synced May 18, 2026
- EUDAMED 85fafed5-7cde-4304-b9ce-b8170f20a98e 61 fields · synced May 18, 2026