GARDHEN BILANCE
IT-MF-000013019 · Italy · POMIGLIANO D'ARCO
GARDHEN BILANCE is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 41 |
|---|
Most frequent device types declared: BARELLE PER USO GENERICO, LETTI MEDICI ELETTRICI CON SISTEMA DI PESATURA, LETTI MEDICI PER TRATTAMENTO, DIAGNOSI E MONITORAGGIO, POLTRONE MEDICALI ELETTRICHE CON SISTEMA DI PESATURA, POLTRONE OPERATORIE.
Among these devices, 41 are declared active, 18 with a measuring function.
Devices declared under this manufacturer
- ATHENA
- ATHENA SCALE
- DAVIDE
- FRANCIS SCALE AV
- GARDHENIA LETTO PSICHIATRICO
- OSCAR
- PASCAL
- RUBENS
- STEPHEN
- STEPHEN SCALE H FREEDOM
- Stephen H Anatomical
- Stephen H Comfort Vers.2
Showing 12 of 41 declared devices.
Catalogue references include 2232817, 2525649, 2576580, 2605791, 2691811, 34870.
European nomenclature codes declared: V08020101, V08020102, V08060101, V08060105, V080603, Z12011201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 41 |
| 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 | 41 |
|---|---|
| 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. GARDHEN BILANCE was not found in either the U.S. or the Canadian register.