← Back to catalogue
Total Triiodothyronine Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2066E-150Ref S2066E-25Ref S2066E-100Ref S2066E-200
Identity
- Device Name
- Total Triiodothyronine Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2066E-150 EUDAMEDS2066E-25 EUDAMEDS2066E-100 EUDAMEDS2066E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740785 EUDAMED06955792740747 EUDAMED06955792740778 EUDAMED06955792740792 EUDAMED
- Basic UDI-DI
- B-06955792740785 EUDAMEDB-06955792740747 EUDAMEDB-06955792740778 EUDAMEDB-06955792740792 EUDAMED
- EMDN Code
- W01020405 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
Total 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-06955792740785 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 94eec207-f5d0-40ef-b408-ab01bde89625 61 fields · synced Jul 22, 2026
- EUDAMED 7746062d-f4d3-471a-9bf1-e9c24ea1d455 61 fields · synced May 17, 2026
- EUDAMED fc690297-f818-4492-b1fb-548735f07da3 61 fields · synced May 17, 2026
- EUDAMED 306ee76c-b1c4-4ebb-a993-331c86962be9 61 fields · synced May 19, 2026