Australia TGA ARTG record

Camera, fundus

Australia TGA ARTG Registered Device · Designs for Vision Aust Pty Ltd · Tianjin Suowei Electronic Technology Co Ltd · Class I · Started January 19, 2024

Good Name: Designs for Vision Aust Pty Ltd - Camera, fundus

Device classification

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

Registration information

Start Date: January 19, 2024
Effective Date: January 19, 2024

Sponsor

Name: Designs for Vision Aust Pty Ltd

Manufacturer

Name: Tianjin Suowei Electronic Technology Co Ltd
Country: China
Address: 2 Building No 6 Zhuyuan Road, Huayuan Industrial Zone, Tianjin, 300384

Intended purpose

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

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 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.