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Self-care monitoring web-based application software - ARTG 391476

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 registered under ARTG number 391476 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 391476
Class IIa
Self-care monitoring web-based application software
ARTG ID: 391476
Good Name: Lowenstein Medical Australia Pty Ltd - Self-care monitoring web-based application software
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Pricing
Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
391476
Start Date
June 29, 2022
Effective Date
June 29, 2022
Manufacturer
Country
Germany
Address
Kronsaalsweg 40, Hamburg, 22525