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.
Devices declared under this manufacturer
- IOL MINI WELL +29.00D
- IOL MINI WELL +30.00D
- IOL MINI WELL PROXA +17.50D
- IOL MINI WELL PROXA TORIC +07.0SE CL3.5
- IOL MINI WELL PROXA TORIC +09.5SE CL3
- IOL MINI WELL PROXA TORIC +09.5SE CL3.5
- IOL MINI WELL PROXA TORIC +12.5SE CL2.5
- IOL MINI WELL PROXA TORIC +20.5SE CL1.5
- IOL MINI WELL PROXA TORIC +27.0SE CL2.5
- IOL MINI WELL PROXA TORIC +29.5SE CL2.5
- IOL MINI WELL TORIC +22.0SE CL1.5
- IOL MINI WELL TORIC +24.0SE CL1.5
Showing 12 of 929 declared devices.
Catalogue references include 1110ACH, 1121CCZ, 1131CCZ, HA GEL, SF 104-XNT/ATS, X7560CZ.
European nomenclature codes declared: P030102100302, P030102100202, Q0299, P030102090201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 929 |
| 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 | 929 |
|---|---|
| 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. SIFI S.p.A. was not found in either the U.S. or the Canadian register.
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 |