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Stationary oxygen concentrator - ARTG 399673

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 399673 and sponsored by Zone Medical Pty Ltd, manufactured by Longfian Scitech Co Ltd in China. The device registration started on November 21, 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.

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Class IIb
ARTG 399673
Class IIb
Stationary oxygen concentrator
ARTG ID: 399673
Good Name: Zone Medical Pty Ltd - Stationary oxygen concentrator
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Intended Purpose

The Oxygen Concentrator device is used by patients requiring supplemental oxygen. The device supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
399673
Start Date
November 21, 2022
Effective Date
November 21, 2022
Manufacturer
Country
China
Address
2F & 3F East Section Building 12 Power Valley Pioneer Park No 369 Huiyang Street, Baoding, Hebei, 071051