Australia TGA ARTG recordHand-held intraoral dental x-ray system, digital
Australia TGA ARTG Registered Device · Shimadzu Medical Systems Oceania Pty Ltd · Genoray Co Ltd · Class IIb · Started October 25, 2022
Good Name: Shimadzu Medical Systems Oceania Pty Ltd - Hand-held intraoral dental x-ray system, digital
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- October 25, 2022
- Effective Date
- October 25, 2022
- Name
- Genoray Co Ltd
- Country
- South Korea
- Address
- 60 Dunchondaero 541 beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do, 13212
The device is intended to use by trained dentists and dental technicians as a mobile, extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. It is used for both adult and children.
Access comprehensive regulatory information for Hand-held intraoral dental x-ray system, digital in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Shimadzu Medical Systems Oceania Pty Ltd, manufactured by Genoray Co Ltd in South Korea. The device registration started on October 25, 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.