LEONE S.P.A.
IT-MF-000005986 · Italy · Sesto Fiorentino
LEONE S.P.A. is registered in the European database on medical devices as a manufacturer, with 8 570 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 080 |
|---|---|
| Class IIb | 490 |
Most frequent device types declared: ACCESSORY FOR TAD, BITE, DISTALIZER, EXPANSION SCREW, FIXED EXPANDER.
Among these devices, 196 are declared sterile, 490 implantable, 185 reusable, 167 active.
Catalogue references include C1211-30, E1600-30, E8205-23, E8971-10, F2073F03, F4410C944.
European nomenclature codes declared: Q010403, Q010402, Q010499, Q010401, P01020180, Q010399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 570 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 8 570 |
|---|---|
| Found in the U.S. device database | 7 612 |
| Share | 88.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LEONE S.P.A. |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| Class 3 devices | 1 |
| First licensed | 2014-01-10 |
Licence types: Device Family (7), System (2).
Licensed under: LEONE DENTAL SURGICAL INSTRUMENTS (STAINLESS S, LEONE IMPLANT SYSTEM, DENTAL SURGICAL INSTRUMENTS (TITANIUM), EXPANDERS FOR ORTHODONTIC APPLIANCE, ORTHODONTIC EXPANSION SCREWS, LEONE ORTHODONTIC BANDS.
North American profile: Canada only. LEONE S.P.A. holds a Canadian licence but was not found in the U.S. register.