Pure Global

Dental digital imaging sensor, intraoral

Access comprehensive regulatory information for Dental digital imaging sensor, intraoral in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Shimadzu Medical Systems Oceania Pty Ltd, manufactured by Genoray Co Ltd in South Korea. The device registration started on October 21, 2022.

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 IIa
Class IIa
Dental digital imaging sensor, intraoral
Australia TGA ARTG Registered Device
Good Name: Shimadzu Medical Systems Oceania Pty Ltd - Dental digital imaging sensor, intraoral
Pure Global
DJ Fang

DJ Fang

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Intended Purpose

The device is intended for use as intraoral imaging system which obtains dental images. GIX-1 consists of Image acquisition part as an Intraoral Sensor and Image processing Software. It provides excellent quality images to users for diagnosis through processing row images acquired from intraoral sensor.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 21, 2022
Effective Date
October 21, 2022
Manufacturer
Country
South Korea
Address
60 Dunchondaero 541 beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do, 13212