DenTi System Kft.
HU-MF-000006488 · Hungary · Szentes
DenTi System Kft. is registered in the European database on medical devices as a manufacturer, with 42 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 42 |
|---|
Among these devices, 42 are declared reusable.
Devices declared under this manufacturer
- Callus
- Denti
Showing 12 of 42 declared devices.
Catalogue references include 8000-002, 8000-888, BT-MU RP, CP 14.041, DF 8000-025, DF 8000-026.
European nomenclature codes declared: Q010399, Q010299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 42 |
| Country of registration | Hungary |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 42 |
|---|---|
| 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. DenTi System Kft. was not found in either the U.S. or the Canadian register.