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Camera, fundus

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.

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TGA ARTG Official Data
Class I
Class I
Camera, fundus
Australia TGA ARTG Registered Device
Good Name: Eyetelligence Pty Ltd - Camera, fundus
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Intended Purpose

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

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
Manufacturer
Country
China
Address
No 7 MingPu Phase II No 3279 SanLu Road, MinHang District, Shanghai, 201100