Australia TGA ARTG recordAutomated retinopathy analysis system application software
Australia TGA ARTG Registered Device · Eyetelligence Pty Ltd · Eyetelligence Pty Ltd · Class I · Started October 23, 2019
Good Name: Eyetelligence Pty Ltd - Automated retinopathy analysis system application software
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- October 23, 2019
- Effective Date
- October 23, 2019
- Country
- Australia
- Address
- 1101 442 St Kilda Road, Melbourne, VIC, 3004
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.
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.