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 February 25, 2021.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
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
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Eyetelligence Microvascular Health is a Software as a Service product This product intends to assess the retinal vascular system and screen for microvascular health issues of the body, based on full colour fundus photos that are generated from fundus camera. 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
February 25, 2021
Effective Date
February 25, 2021
Manufacturer
Country
Australia
Address
1101 442 St Kilda Road, Melbourne, VIC, 3004