3DHISTECH Kft.
HU-MF-000014337 · Hungary · Budapest
3DHISTECH Kft. is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: PANNORAMIC 150 DX Digital Scanner, PANNORAMIC 250 Flash III DX Digital Scanner, PANNORAMIC 480 DX Digital Scanner, PANNORAMIC 75 DX Digital Scanner.
Devices declared under this manufacturer
- Case Manager DX
- CaseManager DX
- PANNORAMIC 1000 DX Digital Scanner
- PANNORAMIC 150 DX Digital Scanner
- PANNORAMIC 250 Flash III DX Digital Scanner
- PANNORAMIC 480 DX Digital Scanner
- PANNORAMIC 75 DX Digital Scanner
- PANNORAMIC Flash DESK DX Digital Scanner
Showing 12 of 22 declared devices.
Catalogue references include DX-02503-B1200ACAA, DX-02503-F1204ACCA, DX-04801-B1200ABAA, DX-04801-B1200ACAB, DX-04802-B1200ACAA, DX-10001-B1200ACAA.
European nomenclature codes declared: W0202050304, W0202050392.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 22 |
| 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 | 22 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | 3DHISTECH KFT. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2025-11-27 |
Licence types: System (1).
Licensed under: PANNORAMIC DIGITAL SCANNER.
North American profile: Canada only. 3DHISTECH Kft. holds a Canadian licence but was not found in the U.S. register.