de Götzen S.r.l.
IT-MF-000013302 · Italy · Fagnano Olona
de Götzen S.r.l. is registered in the European database on medical devices as a manufacturer, with 281 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 264 |
|---|---|
| Class IIa | 17 |
Most frequent device types declared: Dental intraoral x-ray equipment DC, Dental intraoral x-ray equipment AC, Panoramic, cephalometric and tomographic X-ray equipment, Dental intraoral x-ray equipment XMu, Amalgamator.
Among these devices, 281 are declared active, 1 with a measuring function.
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 | 281 |
| 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 |
|---|---|---|
108/MDR | supplemented | 2028-04-13 |