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: FIXED EXPANDER, EXPANSION SCREW, DISTALIZER, TAD, OSTEOTOMY TIP.
Among these devices, 196 are declared sterile, 490 implantable, 185 reusable, 167 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 570 |
| Country of registration | Italy |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.