← Back to catalogue
Thyroid stimulating hormone Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2094E-48Ref S2094E-24
Identity
- Device Name
- Thyroid stimulating hormone Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- S2094E-48 EUDAMEDS2094E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738294 EUDAMED06955792738287 EUDAMED
- Basic UDI-DI
- B-06955792738294 EUDAMEDB-06955792738287 EUDAMED
- EMDN Code
- W0102100302 TSH RECEPTOR ANTIBODIES 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 Assay Kit (Chemiluminescent Immunoassay) 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-06955792738294 | 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 (2)
- EUDAMED c8400d21-3c64-4871-bce4-479564a0c6d2 61 fields · synced Jul 15, 2026
- EUDAMED 7d0fc863-16fe-47ba-b087-3ab23f919777 61 fields · synced May 18, 2026