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Anti-Thyroglobulin Antibody Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2005E-75Ref S2005E-100Ref S2005E-25Ref S2005E-150Ref S2005E-50
Identity
- Device Name
- Anti-Thyroglobulin Antibody Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2005E-75 EUDAMEDS2005E-100 EUDAMEDS2005E-25 EUDAMEDS2005E-150 EUDAMEDS2005E-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736542 EUDAMED06955792736559 EUDAMED06955792736528 EUDAMED06955792736566 EUDAMED06955792736535 EUDAMED
- Basic UDI-DI
- B-06955792736542 EUDAMEDB-06955792736559 EUDAMEDB-06955792736528 EUDAMEDB-06955792736566 EUDAMEDB-06955792736535 EUDAMED
- EMDN Code
- W0102100303 THYROGLOBULIN AUTOANTIBODY 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
Anti-Thyroglobulin Antibody Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06955792736542 | 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 (5)
- EUDAMED dcbea855-7e72-4c71-aa81-4f05232f0060 61 fields · synced Oct 6, 2026
- EUDAMED 4a3495f7-a121-40f8-b6db-054b25ede5b6 61 fields · synced May 17, 2026
- EUDAMED 4c799a2d-1681-4b44-a60e-97f52522452a 61 fields · synced May 18, 2026
- EUDAMED 19fbc4f3-284e-4f2e-a90e-300578ac690c 61 fields · synced May 18, 2026
- EUDAMED ee37734a-2302-4c61-a953-efec82f72f6d 61 fields · synced May 18, 2026