Identity
- Trade Name
- Free Testosterone ELISA EUDAMEDTestosterone ELISA EUDAMED
- Device Name
- Free Testosterone ELISA EUDAMEDTestosterone ELISA EUDAMED
- Model / Reference
- DB52181 EUDAMEDRE52151 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049325030695 EUDAMED04049325001756 EUDAMED
- Basic UDI-DI
- 4049325IVR06080015BTY EUDAMEDB-04049325001756 EUDAMED
- Direct Marketing DI
- 04049325030695 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
Free Testosterone ELISA by Ibl International Gmbh — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 4049325IVR06080015BTY | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 4049325IVR06080015BTY | Class B | Active |
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Manufacturer
- Manufacturer
- IBL International GmbH
- EUDAMED SRN
- DE-MF-000015709
Sources (2)
- EUDAMED d9a6c28a-56a3-456c-ba67-f43cf893cac4 61 fields · synced Jul 19, 2026
- EUDAMED 3b12b21d-f94f-428f-8b5a-e74390b08903 61 fields · synced Jul 10, 2026