BIEMME GROUP SRL
IT-MF-000031381 · Italy · RUBIERA
BIEMME GROUP SRL 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 |
|---|
Among these devices, 18 are declared active.
Catalogue references include ELEPHANT 2.0 BR, Felix-20X, Jupiter, LEO M1, LEO M2, LEONCINO M2.
European nomenclature codes declared: Y050202, Y050201, Y122106, Y180939.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| 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 | 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. BIEMME GROUP SRL was not found in either the U.S. or the Canadian register.