Dentalia Dentálgyártmány Kft.
HU-MF-000008310 · Hungary · BICSKE
Dentalia Dentálgyártmány Kft. is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 18 |
|---|
Devices declared under this manufacturer
- Denta kék nyálkendő
- Fejtámlavédő
- Fejtámlavédő minta
- Minta Simplex, Simplex-Plus
- Minta Simplex-Plus Maxi
- Simplex fehér nyálkendő
- Simplex kék nyálkendő
- Simplex zöld nyálkendő
- Simplex-Plus Maxi fehér nyálkendő
- Simplex-Plus Maxi kék nyálkendő
- Simplex-Plus Maxi zöld nyálkendő
- Simplex-Plus fehér nyálkendő
Showing 12 of 18 declared devices.
Catalogue references include 5436, 5452, 5532, 645001, 645002, 647101.
European nomenclature codes declared: T0306.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| 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 | 18 |
|---|---|
| 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. Dentalia Dentálgyártmány Kft. was not found in either the U.S. or the Canadian register.