Australia TGA ARTG record

Camera, fundus

Australia TGA ARTG Registered Device · Eyetelligence Pty Ltd · Shanghai Mediworks Precision Instruments Co · Class I · Started October 13, 2021

Good Name: Eyetelligence Pty Ltd - Camera, fundus

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 13, 2021
Effective Date: October 13, 2021

Sponsor

Name: Eyetelligence Pty Ltd

Manufacturer

Name: Shanghai Mediworks Precision Instruments Co
Country: China
Address: No 7 MingPu Phase II No 3279 SanLu Road, MinHang District, Shanghai, 201100

Intended purpose

This device is intended for observing, photographing and obtaining retinal images without mydriasis optometry and is not intended for diagnosis or treatment.

About this record

Access comprehensive regulatory information for Camera, fundus 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 Shanghai Mediworks Precision Instruments Co in China. The device registration started on October 13, 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.