FOTONA, proizvodnja optoelektronskih naprav d.o.o.
SI-MF-000000126 · Slovenia · Ljubljana
FOTONA, proizvodnja optoelektronskih naprav d.o.o. is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 29 |
|---|---|
| Class IIa | 2 |
Among these devices, 31 are declared active.
Devices declared under this manufacturer
- AvalancheLase
- LightWalker AT
- LightWalker AT S
- LightWalker ST-E ADVANCED
- LightWalker ST-E PRO
- SP Dynamis
- SP Spectro
- SkyPulse
- SkyWave
- StarFormer
- StarWalker
- TimeWalker AT
Showing 12 of 31 declared devices.
Catalogue references include M021-4AF/3, M021-5AF/1, M021-5AF/1 S, M031-3A/2 MAQX, M031-3A/2 PICO Pro, M031-3A/2 PQX.
European nomenclature codes declared: Z12011019, Z120606, Z12011016.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 31 |
| 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 | 31 |
|---|---|
| Found in the U.S. device database | 28 |
| Share | 90.3 % |
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. FOTONA, proizvodnja optoelektronskih naprav d.o.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 025155 0029 | issued | 2027-01-18 |
2022-MDR/QS-021/A | issued | 2027-09-21 |