Orodent srl
IT-MF-000030463 · Italy · Castelnuovo del Garda
Orodent srl is registered in the European database on medical devices as a manufacturer, with 580 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 580 |
|---|
Most frequent device types declared: 805415427DZIRC01JV, 805415427DZIRC02JX, 805415427CZR0188.
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 | 580 |
| 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 |
|---|---|---|
190/MDR | supplemented | 2029-12-11 |