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Stationary oxygen concentrator - ARTG 443510

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 registered under ARTG number 443510 and 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
ARTG 443510
Class IIb
Stationary oxygen concentrator
ARTG ID: 443510
Good Name: iJoysBio Pty Ltd - Stationary oxygen concentrator
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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
ARTG ID
443510
Start Date
March 11, 2024
Effective Date
March 11, 2024
Sponsor
Manufacturer
Country
China
Address
No 1 Baisheng Road Development Zone, Danyang, Jiangsu, 212300