Pure Global

Stationary oxygen concentrator

Access comprehensive regulatory information for Stationary oxygen concentrator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by iJoysBio Pty Ltd, manufactured by Jiangsu Yuyue Medical Equipment & Supply Co Ltd in China. The device registration started on March 11, 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.

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Class IIb
Class IIb
Stationary oxygen concentrator
Australia TGA ARTG Registered Device
Good Name: iJoysBio Pty Ltd - Stationary oxygen concentrator
Pure Global
DJ Fang

DJ Fang

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Intended Purpose

This oxygen concentrator is intended for individual use as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 11, 2024
Effective Date
March 11, 2024
Sponsor
Manufacturer
Country
China
Address
No 1 Baisheng Road Development Zone, Danyang, Jiangsu, 212300