ENABLE INNOVATIONS SRL
IT-MF-000026066 · Italy · CARPI (MO)
ENABLE INNOVATIONS SRL is registered in the European database on medical devices as a manufacturer, with 192 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 180 |
|---|---|
| Class IIa | 12 |
Most frequent device types declared: Gocce oculari Innodrops BB, Gocce oculari Innodrops F1a, Gocce oculari Innodrops F1b, Gocce oculari Innodrops X, Soluzione inalatoria S3.
Among these devices, 191 are declared sterile.
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 | 192 |
| 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 |
|---|---|---|
0425-MDR-030179-00 | issued | 2031-03-22 |
0425-MDR-030120-00 | issued | 2030-02-02 |
0425-MDR-030119-01 | supplemented | 2030-02-02 |
0425-MDR-030020-01 | supplemented | 2028-02-26 |