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Camera, fundus - ARTG 435830

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 registered under ARTG number 435830 and sponsored by Designs for Vision Aust Pty Ltd, manufactured by Tianjin Suowei Electronic Technology Co Ltd in China. The device registration started on January 19, 2024.

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
ARTG 435830
Class I
Camera, fundus
ARTG ID: 435830
Good Name: Designs for Vision Aust Pty Ltd - Camera, fundus
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Intended Purpose

Ophthalmic Wide Field Imaging System for real-time color imaging of the neonatal mydriatic fundus by virtue of optical imaging.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
435830
Start Date
January 19, 2024
Effective Date
January 19, 2024
Manufacturer
Country
China
Address
2 Building No 6 Zhuyuan Road, Huayuan Industrial Zone, Tianjin, 300384