SIS Ltd., Surgical Instrument System

SIS Ltd. specializes in ophthalmic diagnostic imaging systems. Specifically, they produce the Galilei G4, which is a corneal topography and tomography device. This system maps the cornea’s surface and thickness in detail, aiding in preoperative planning and postoperative evaluations for refractive surgeries like LASIK or PRK.

SIS Ltd. is headquartered in Switzerland, as indicated by the country designation (CH). The company’s location is relevant for regulatory compliance, manufacturing standards, and distribution within the European market.

The Galilei G4, SIS Ltd.’s primary device, is listed in the eudamed registry, which is the EU’s central database for medical devices. Listing in eudamed is mandatory for Class IIa devices under EU MDR, ensuring transparency and traceability for healthcare professionals and authorities.

The Galilei G4 falls under Class IIa classification, which is determined by its intended use and associated risks. Class IIa devices require conformity assessment procedures, including clinical evaluations and risk management, to ensure safety and performance before market placement. This classification reflects its role in diagnostic imaging for corneal assessment.