Pure Global

X-ray system, diagnostic, fluoroscopic, general-purpose, mobile, digital

Access comprehensive regulatory information for X-ray system, diagnostic, fluoroscopic, general-purpose, mobile, 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 September 27, 2021.

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, fluoroscopic, general-purpose, mobile, digital
Australia TGA ARTG Registered Device
Good Name: Shimadzu Medical Systems Oceania Pty Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, mobile, digital
Pure Global
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Intended Purpose

The device is a mobile C-Arm X-ray system, is intended to provide fluoroscopic and radiographic X-ray images of the patient during diagnosis urologic, orthopedic, neurologic, anesthesiology and others

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 27, 2021
Effective Date
September 27, 2021
Manufacturer
Country
South Korea
Address
60 Dunchondaero 541 beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do, 13212