iVis Technologies S.r.l.

iVis Technologies S.r.l. specializes in ophthalmic medical devices. Their portfolio includes intraocular lenses such as the B60, AA60, and AM60, which are implanted within the eye. Additionally, they produce diagnostic tools like the Cipta and Clat for ophthalmic assessment, the iRes for intraocular measurements, and the Precisio for precision surgical guidance. They also offer the SafeCross for surgical navigation and the pMetrics for monitoring intraocular pressure.

iVis Technologies S.r.l. is based in Italy. The company’s headquarters and operations are located within the country, which aligns with its focus on European regulatory compliance and market presence.

All of iVis Technologies S.r.l.’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry ensures transparency and compliance with EU medical device regulations, allowing healthcare professionals and authorities to verify the devices’ details and regulatory status.

iVis Technologies S.r.l.’s devices are classified under EU medical device classes IIa and IIb. Class IIa devices pose a low-to-moderate risk and require conformity assessment procedures, while Class IIb devices carry a higher risk, necessitating additional scrutiny such as clinical evaluations or designated body involvement. The classification ensures appropriate regulatory oversight based on the device’s potential risk to patient safety.