UNIVET LOUPES SPA
IT-MF-000027104 · Italy · Rezzato (BS)
UNIVET LOUPES SPA is registered in the European database on medical devices as a manufacturer, with 4 577 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 4 577 |
|---|
Most frequent device types declared: ASH, ITA, ITA BLACK EDITION, MODEL 3, MODEL 3 GO.
Among these devices, 6 are declared active.
Catalogue references include KK66134.0A, KKA015333C, KKA025533, KKA052433, KKA063633C, KKA110134.
European nomenclature codes declared: L0399, Z129004.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | UNIVET LOUPES SPA (IT) · FDA 3018898827 |
| Devices in EUDAMED | 4 577 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 4 577 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 0.1 % |
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. UNIVET LOUPES SPA is registered in the United States but was not found in the Canadian register.