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.
Devices declared under this manufacturer
- AsTer Total Care
- EMOLIFE
- EMOLIFE / E-DELPHYN MD
- EMONET
- NGH MD
- PHEBO
- TENGEER
Catalogue references include AsTer Total Care, EMOLIFE, EMOLIFE / E-DELPHYN MD, EMONET, NGH MD, PHEBO.
European nomenclature codes declared: Z121799, Z12030292, Z11069092, Z12040292, V92.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 8 |
|---|---|
| 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. GPI S.P.A. was not found in either the U.S. or the Canadian register.
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 |