Australia TGA ARTG record

Self-care monitoring web-based application software

Australia TGA ARTG Registered Device · Lowenstein Medical Australia Pty Ltd · Lowenstein Medical Technology GmbH Co Kg · Class IIa · Started June 29, 2022

Good Name: Lowenstein Medical Australia Pty Ltd - Self-care monitoring web-based application software

Device classification

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

Registration information

Start Date: June 29, 2022
Effective Date: June 29, 2022

Sponsor

Name: Lowenstein Medical Australia Pty Ltd

Manufacturer

Name: Lowenstein Medical Technology GmbH Co Kg
Country: Germany
Address: Kronsaalsweg 40, Hamburg, 22525

Intended purpose

prisma APP is a mobile application to support patients being treated with compatible Löwenstein Medical Technology positive airway pressure devices by providing therapy related information and remote control.

About this record

Access comprehensive regulatory information for Self-care monitoring web-based application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Lowenstein Medical Australia Pty Ltd, manufactured by Lowenstein Medical Technology GmbH Co Kg in Germany. The device registration started on June 29, 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.