SIFI S.p.A.
IT-MF-000020853 · Italy · Aci Sant'antonio Catania
SIFI S.p.A. is registered in the European database on medical devices as a manufacturer, with 929 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 928 |
|---|---|
| Class I | 1 |
Most frequent device types declared: 1110ACHPXXXXA.
Among these devices, 929 are declared sterile, 925 implantable.
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 | 929 |
| 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 |
|---|---|---|
CVD0015230125 | issued | 2028-09-21 |
028-00-02-MDR | supplemented | 2028-08-31 |
027-00-07-MDR | supplemented | 2028-08-31 |