Australia TGA ARTG record

Single-chamber venous compression system garment, reprocessed

Australia TGA ARTG Registered Device · Arjo Australia Pty Ltd · Arjo Australia Pty Ltd · Class I · Started May 18, 2023

Good Name: Arjo Australia Pty Ltd - Single-chamber venous compression system garment, reprocessed

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 18, 2023
Effective Date: May 18, 2023

Sponsor

Name: Arjo Australia Pty Ltd

Manufacturer

Name: Arjo Australia Pty Ltd
Country: Australia
Address: Level 3 Building B 11 Talavera Road, Macquarie Park, NSW, 2113

Intended purpose

A non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a previously used single-use device that has been processed for an additional single-use patient application

About this record

Access comprehensive regulatory information for Single-chamber venous compression system garment, reprocessed in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Arjo Australia Pty Ltd, manufactured by Arjo Australia Pty Ltd in Australia. The device registration started on May 18, 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.