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Testosterone (TESTO) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/KitRef 100 Tests/Kit
Identity
- Trade Name
- Testosterone (TESTO) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Testosterone (TESTO) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 50 Tests/Kit EUDAMED100 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986814637 EUDAMED06974986814644 EUDAMED
- Basic UDI-DI
- B-06974986814637 EUDAMEDB-06974986814644 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Testosterone (TESTO) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — 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-06974986814637 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED baa57005-d2e7-4c73-b1c4-3471cd89a7c8 61 fields · synced Oct 6, 2026
- EUDAMED c1844bdf-6d78-4018-a414-6b012b8acac2 61 fields · synced May 17, 2026