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Extremity-oxygenation hyperbaric chamber, powered

Access comprehensive regulatory information for Extremity-oxygenation hyperbaric chamber, powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Device Services Australia Pty Ltd, manufactured by AOTI Ltd in Ireland. The device registration started on March 31, 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 IIa
Class IIa
Extremity-oxygenation hyperbaric chamber, powered
Australia TGA ARTG Registered Device
Good Name: Device Services Australia Pty Ltd - Extremity-oxygenation hyperbaric chamber, powered
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Intended Purpose

The AOTI Hyper-Box Homecare System is intended for 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 IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
March 31, 2023
Effective Date
March 31, 2023
Manufacturer
Country
Ireland
Address
Unit 20 Glenrock Business Park, Ballybane, Galway