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: 805415427CZR0188, 805415427DZIRC01JV, 805415427DZIRC02JX.
Devices declared under this manufacturer
- ORODENT EOS B2
- ORODENT ERA A0
- ORODENT ERA A1
- ORODENT ERA B2
- ORODENT HECTOR A0
- ORODENT LUX A1
- ORODENT LUX D3
- ORODENT PRESHADED A1
- ORODENT PRESHADED A3
- ORODENT THOR A3,5
- ORODENT THOR A4
- ORODENT THOR B3
Showing 12 of 580 declared devices.
Catalogue references include ZR9814MSTB3, ZR9816MSTA35/ZR9516MSTA35, ZR9816TA1/ZR9516TA1, ZR9820TA3/ZR9520TA3, ZR9825MSTC1, ZS9812MSA0.
European nomenclature codes declared: Q010699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 580 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 580 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. Orodent srl was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
190/MDR | supplemented | 2029-12-11 |