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Testosterone Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2060E-50Ref S2060E-25Ref S2060E-150Ref S2060E-200
Identity
- Device Name
- Testosterone Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2060E-50 EUDAMEDS2060E-25 EUDAMEDS2060E-150 EUDAMEDS2060E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740396 EUDAMED06955792740389 EUDAMED06955792740426 EUDAMED06955792740433 EUDAMED
- Basic UDI-DI
- B-06955792740396 EUDAMEDB-06955792740389 EUDAMEDB-06955792740426 EUDAMEDB-06955792740433 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
Developed for medical professionals, the Testosterone Chemiluminescence Immunoassay Kit provides a reliable and precise method for measuring testosterone levels. This accurate test is essential for diagnosing and monitoring conditions such as hypogonadism or low libido in both men and women.
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-06955792740396 | 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 e3c2e44e-22e9-4ff5-bfc9-14fedf7c04fb 61 fields · synced Jul 26, 2026
- EUDAMED 867bacf2-1504-48d0-a445-18e6626a1d23 61 fields · synced May 17, 2026
- EUDAMED 2a944673-3096-42ec-94c0-fc80c1b2e6c0 61 fields · synced May 17, 2026
- EUDAMED eee2844e-e51c-43a6-b687-52286332c207 61 fields · synced May 18, 2026