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Thyroglobulin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2153E-150Ref S2153E-25Ref S2153E-75Ref S2153E-50Ref S2153E-200Ref S2153E-100
Identity
- Device Name
- Thyroglobulin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2153E-150 EUDAMEDS2153E-25 EUDAMEDS2153E-75 EUDAMEDS2153E-50 EUDAMEDS2153E-200 EUDAMEDS2153E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792743007 EUDAMED06955792742963 EUDAMED06955792742987 EUDAMED06955792742970 EUDAMED06955792743014 EUDAMED06955792742994 EUDAMED
- Basic UDI-DI
- B-06955792743007 EUDAMEDB-06955792742963 EUDAMEDB-06955792742987 EUDAMEDB-06955792742970 EUDAMEDB-06955792743014 EUDAMEDB-06955792742994 EUDAMED
- EMDN Code
- W01020408 THYROGLOBULIN 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
Thyroglobulin 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-06955792743007 | 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 (6)
- EUDAMED bf074b5b-2435-4442-b2f6-203b1c10bbb8 61 fields · synced Jul 31, 2026
- EUDAMED cd3b435d-d859-49b6-a386-c6ab0be1ce29 61 fields · synced May 16, 2026
- EUDAMED fc14e075-3a4f-41d7-802b-fb1f7bd9e781 61 fields · synced May 17, 2026
- EUDAMED e6c6ad52-bfc4-4b70-969d-7252411fcd8d 61 fields · synced May 17, 2026
- EUDAMED 9ce06132-9f84-4347-b6e9-504cfbac7074 61 fields · synced May 18, 2026
- EUDAMED db43e729-4175-4463-94bb-533317ab827b 61 fields · synced May 18, 2026