BONE SYSTEM SRL
IT-MF-000040985 · Italy · Garbagnate Milanese (MI)
BONE SYSTEM SRL is registered in the European database on medical devices as a manufacturer, with 506 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 399 |
|---|---|
| Class IIa | 107 |
Most frequent device types declared: Two-stage dental implant, Dental implant (monophasic).
Among these devices, 138 are declared sterile, 399 implantable, 107 reusable, 107 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 | 506 |
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030161-00 | issued | 2030-12-01 |