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: Amalgamator, Dental intraoral x-ray equipment AC, Dental intraoral x-ray equipment DC, Dental intraoral x-ray equipment XMu, Panoramic, cephalometric and tomographic X-ray equipment.
Among these devices, 281 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- Leadex70
- Leadex70 dc
- Softly
- Softly 8
- U-SENSE
- U-SENSE HD
- X-MIND prime
- X-MIND unity
- x-mind ac
- x-mind dc
- xgenus
- xgenus Aries
Showing 12 of 281 declared devices.
Catalogue references include 5.90.15076, 5.90.22032, 5.90.23033, 5.90.23365, 5.92.23058, 5.93.23231.
European nomenclature codes declared: Z1103040101,Z1103040102, Z1103030102,Z11030302, Z12119002, Z1103030102, Z11030402, Z1103030102,Z11030402.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 281 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. de Götzen S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
108/MDR | supplemented | 2028-04-13 |