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Extremity-oxygenation hyperbaric chamber, non-powered - ARTG 410180

Access comprehensive regulatory information for Extremity-oxygenation hyperbaric chamber, non-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 410180 and sponsored by Device Services Australia Pty Ltd, manufactured by AOTI Ltd in Ireland. The device registration started on June 07, 2023.

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 I
ARTG 410180
Class I
Extremity-oxygenation hyperbaric chamber, non-powered
ARTG ID: 410180
Good Name: Device Services Australia Pty Ltd - Extremity-oxygenation hyperbaric chamber, non-powered
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Intended Purpose

A non-invasive, non-active, non-sterile, single-use (disposable) flexible plastic chamber intended to hermetically surround a patient's limb for the topical application of oxygen from an oxygen gas supply at a pressure greater than atmospheric for the treatment of slow-healing wounds of the extremities. These are primarily wounds associated with diabetic and geriatric patients (Venous ulcers etc.).

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
410180
Start Date
June 07, 2023
Effective Date
June 07, 2023
Manufacturer
Country
Ireland
Address
Unit 20 Glenrock Business Park, Ballybane, Galway