Audax d.o.o.
SI-MF-000030083 · Slovenia · Ljubljana
Audax d.o.o. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Among these devices, 6 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- AudaxCeph Essentials
- AudaxCeph Ultimate
- AudaxCeph for Cloud
- Romexis Cephalometric Analysis Module
- VistaSoft Trace
- WeDoCeph
Catalogue references include 1, 2, 3, 4, 5, 6.
European nomenclature codes declared: Z119092.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Slovenia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Audax d.o.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0029 | issued | 2030-05-22 |