GreenBone Ortho Spa
IT-MF-000033034 · Italy · Faenza
GreenBone Ortho Spa is registered in the European database on medical devices as a manufacturer, with 83 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 83 |
|---|
Among these devices, 83 are declared sterile, 83 implantable.
Devices declared under this manufacturer
- b.Bone
Showing 12 of 83 declared devices.
Catalogue references include HC100030PS, HC150610PS, HC150640PS, HC251320PS, HC251330PS, HP301510PS.
European nomenclature codes declared: P900401.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 83 |
| 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 | 83 |
|---|---|
| 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. GreenBone Ortho Spa was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
044-00-01-MDR | supplemented | 2029-03-05 |