GPI S.P.A.
IT-MF-000020127 · Italy · TRENTO
GPI S.P.A. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 4 |
|---|---|
| Class IIb | 4 |
Most frequent device types declared: POHEMA (versione 2).
Among these devices, 8 are declared active, 1 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Italy |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT321284 | supplemented | 2028-02-22 |
IT321284 | issued | 2028-02-22 |
IT321284 | reissued | 2028-02-22 |
061-00-00-MDR | issued | 2029-10-22 |