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Testosterone Saliva Luminescence Immunoassay
EUDAMEDClass B (EU MDR)
Ref 30191569Ref 30191568
Identity
- Trade Name
- Testosterone Saliva Luminescence Immunoassay EUDAMED
- Device Name
- Testosterone Saliva Luminescence Immunoassay EUDAMED
- Model / Reference
- 30191569 EUDAMED30191568 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049325030473 EUDAMED04049325030480 EUDAMED
- Basic UDI-DI
- 4049325IVR06080007BTZ EUDAMED
- Direct Marketing DI
- 04049325030473 EUDAMED04049325030480 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Testosterone Saliva Luminescence Immunoassay by Ibl International Gmbh — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4049325IVR06080007BTZ | Class B | Active |
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Manufacturer
- Manufacturer
- IBL International GmbH
- EUDAMED SRN
- DE-MF-000015709
Sources (2)
- EUDAMED 15bb32e3-abac-4b43-bb77-26c8658ccb9e 61 fields · synced Aug 2, 2026
- EUDAMED 9fe4e5b3-de7e-4b79-b83e-fc7761da422e 61 fields · synced May 18, 2026