LINEA One Kft.
HU-MF-000028125 · Hungary · Győr
LINEA One Kft. is registered in the European database on medical devices as a manufacturer, with 56 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 56 |
|---|
Among these devices, 56 are declared with a measuring function.
Catalogue references include HB10000, HB10002, HB11301, HB11302, HB11401, HB11408.
European nomenclature codes declared: V08060101, V0806010701, V08060102, V080603, V0809, V080699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 56 |
| 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 | 56 |
|---|---|
| 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. LINEA One Kft. was not found in either the U.S. or the Canadian register.