Anterior eye segment analysis system - ARTG 484430
Access comprehensive regulatory information for Anterior eye segment analysis system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 484430 and sponsored by Kevin Grundy (IBD) Pty Ltd, manufactured by SIS Ltd Surgical Instrument Systems in Switzerland. The device registration started on March 27, 2025.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The GALILEI is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate: • Corneal shape • Pachymetry (corneal thickness) • Position of the cornea relative to iris and lens • Corneal and lenticular opacity • Condition of the ocular surface • Anterior chamber angle • Anterior chamber depth • Volume of the anterior chamber • White-to-white distance • Pupil size • Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings) • Location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry • Condition of the lens (opaque crystalline lens) • Lens shape • Crystalline lens thickness The GALILEI G6 is designed to additionally evaluate: • Axial length The GALILEI also performs calculations to assist physicians in determining the power of an intraocular lens for implantation.