Pure Global

Automated retinopathy analysis system application software

Access comprehensive regulatory information for Automated retinopathy analysis system application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Eyetelligence Pty Ltd, manufactured by Eyetelligence Pty Ltd in Australia. The device registration started on October 23, 2019.

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.

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Class I
Class I
Automated retinopathy analysis system application software
Australia TGA ARTG Registered Device
Good Name: Eyetelligence Pty Ltd - Automated retinopathy analysis system application software
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Intended Purpose

The Eyetelligence system is intended to screen and grade Diabetic Retinopathy (DR), Cataract, Aged Related Macular Degeneration (AMD) and Glaucoma in patients/consumers through retinal images. The Eyetelligence system outcomes are intended to be subsequently verified and certified by a qualified medical/eye care professional who will make a clinical decision based on a range of inputs not limited to Eyetelligence outcomes.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 23, 2019
Effective Date
October 23, 2019
Manufacturer
Country
Australia
Address
1101 442 St Kilda Road, Melbourne, VIC, 3004