SIFI S.p.A.

SIFI S.p.A. specializes in intraocular lenses (IOLs) and surgical kits used primarily for cataract surgery. Their portfolio includes toric IOLs (for correcting astigmatism) and multifocal IOLs (for addressing presbyopia), along with associated implantation kits. These devices are designed to restore vision in patients with cataracts or refractive errors during phacoemulsification procedures.

SIFI S.p.A. is based in Italy, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since their products are Class IIb and Class III devices, they must comply with the EU Medical Device Regulation (MDR) and are registered in the EU’s official database, eudamed, to ensure traceability and regulatory transparency.

SIFI S.p.A.’s devices are listed in eudamed, the European Union’s central registry for medical devices. This database is required for Class IIb and Class III devices under EU MDR, ensuring their compliance and traceability within the European market.

SIFI S.p.A.’s devices fall into Class IIb and Class III categories under EU medical device legislation. Class IIb devices pose moderate risks (e.g., certain IOLs with additional functions), while Class III devices, like some advanced IOLs, are considered high-risk and require rigorous pre-market approval processes to ensure safety and performance.