ORTHODONTICS HIGH DESIGN SRL
IT-MF-000020077 · Italy · BOLOGNA
ORTHODONTICS HIGH DESIGN SRL is registered in the European database on medical devices as a manufacturer, with 57 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 57 |
|---|
Most frequent device types declared: 3FLEX CLEAR, IPR STRIPPING GAUGE, MEMOCLEAR PRO, SMART PLIERS.
Among these devices, 38 are declared active.
Catalogue references include TP-001-077/SM, TP-001-083/SM, TP-3435-100, TP-3438, TP-3440, TP-3441-100.
European nomenclature codes declared: Q010499, L150702.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 57 |
| 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 | 57 |
|---|---|
| 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. ORTHODONTICS HIGH DESIGN SRL was not found in either the U.S. or the Canadian register.