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Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2063E-100Ref S2063E-75
Identity
- Device Name
- Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2063E-100 EUDAMEDS2063E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740594 EUDAMED06955792740587 EUDAMED
- Basic UDI-DI
- B-06955792740594 EUDAMEDB-06955792740587 EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE 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
Thyroid Stimulating Hormone 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-06955792740594 | 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 (2)
- EUDAMED 9ab76845-5915-4b36-8bfe-7317216153a1 61 fields · synced Jul 23, 2026
- EUDAMED 5c379c2c-ad8c-4dde-aec6-1b8b09d474d3 61 fields · synced May 17, 2026