Luxottica Group S.p.A
IT-MF-000041132 · Italy · Milano
Luxottica Group S.p.A is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 22 |
|---|
Most frequent device types declared: AAW0001EL, AAW0002EL, AW5001354.
Among these devices, 22 are declared active.
Devices declared under this manufacturer
- Nuance Audio
Showing 12 of 22 declared devices.
Catalogue references include AAW0001EL, AW5001454, AW5001554, AW5001754, AW5004456, AW5004656.
European nomenclature codes declared: Y2145060101, Y214580.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LUXOTTICA GROUP S.P.A (IT) · FDA 3011016506 |
| Devices in EUDAMED | 22 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 22 |
|---|---|
| Found in the U.S. device database | 16 |
| Share | 72.7 % |
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: United States only. Luxottica Group S.p.A is registered in the United States but was not found in the Canadian register.