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Free Testosterone Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2139E-100Ref S2139E-25Ref S2139E-75Ref S2139E-150
Identity
- Device Name
- Free Testosterone Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2139E-100 EUDAMEDS2139E-25 EUDAMEDS2139E-75 EUDAMEDS2139E-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742178 EUDAMED06955792742147 EUDAMED06955792742161 EUDAMED06955792742185 EUDAMED
- Basic UDI-DI
- B-06955792742178 EUDAMEDB-06955792742147 EUDAMEDB-06955792742161 EUDAMEDB-06955792742185 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) 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
Free Testosterone 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-06955792742178 | 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 (4)
- EUDAMED fce68574-bf9c-47cf-8751-31535d92d9c9 61 fields · synced Jul 21, 2026
- EUDAMED 1c740cbf-ef3b-4e07-8991-05cd2e6c4cce 61 fields · synced May 18, 2026
- EUDAMED fb515099-62a7-4fe6-ae13-291d30030e11 61 fields · synced May 18, 2026
- EUDAMED aed11328-4c58-4f7e-b6e2-2e5c52e5be40 61 fields · synced May 19, 2026