Alcom d.o.o.
SI-MF-000004685 · Slovenia · Kranj
Alcom d.o.o. is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 17 |
|---|
Most frequent device types declared: ACM, BIF, ISV, MGA, MMX.
Among these devices, 5 are declared active.
Devices declared under this manufacturer
- Bifokal z dioptrijo
- Delovno steklo z dioptrijo
- Dioptrijska očala
- Enožariščna mineralna oftalmična stekla
- Enožariščna organska oftalmična stekla
- Enožariščno steklo z dioptrijo
- Progresivna mineralna oftalmična stekla
- Progresivna organska oftalmična stekla
Showing 12 of 17 declared devices.
Catalogue references include Acomoda, Single Vision, Relax, Bifocal, Bifo, R28, S28, C28, Individual Single Vision, Magic Gamma, Magic Max, Magic Sport.
European nomenclature codes declared: Q0210010103, Q0210010101, Q0210010102, Q0210010201, Q0210030103, Q0210010203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| 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 | 17 |
|---|---|
| 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. Alcom d.o.o. was not found in either the U.S. or the Canadian register.