Pure Global

X-ray system, diagnostic, general-purpose, hand-held, digital

Access comprehensive regulatory information for X-ray system, diagnostic, general-purpose, hand-held, digital in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medical Equipment Australia Pty Ltd, manufactured by Ningbo Runyes Medical Instrument Co Ltd in China. The device registration started on June 30, 2009.

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 IIb
Class IIb
X-ray system, diagnostic, general-purpose, hand-held, digital
Australia TGA ARTG Registered Device
Good Name: Medical Equipment Australia Pty Ltd - X-ray system, diagnostic, general-purpose, hand-held, digital
Pure Global
DJ Fang

DJ Fang

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Intended Purpose

Used to Xray the teeth and Mouth. The device is designed to diagnose and determine oral cavities and conditions of the teeth, an provide an image for the Dentist to be able to treat the determined condition.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 30, 2009
Effective Date
June 30, 2009
Manufacturer
Country
China
Address
456 Tonghui Road Jiangbei Investment & Pioneering Park C, Ningbo, 315033