Australia TGA ARTG recordExtremity-oxygenation hyperbaric chamber, non-powered
Australia TGA ARTG Registered Device · Device Services Australia Pty Ltd · AOTI Ltd · Class I · Started June 07, 2023
Good Name: Device Services Australia Pty Ltd - Extremity-oxygenation hyperbaric chamber, non-powered
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- June 07, 2023
- Effective Date
- June 07, 2023
- Name
- AOTI Ltd
- Country
- Ireland
- Address
- Unit 20 Glenrock Business Park, Ballybane, Galway
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.).
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 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.