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Self-care monitoring web-based application software - ARTG 381292

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 I is registered under ARTG number 381292 and sponsored by Roche Products Pty Ltd, manufactured by Roche Molecular Systems Inc in United States of America. The device registration started on December 23, 2021.

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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Class I
ARTG 381292
Class I
Self-care monitoring web-based application software
ARTG ID: 381292
Good Name: Roche Products Pty Ltd - Self-care monitoring web-based application software
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Intended Purpose

Software program designed for the continual to collect and aggregate a patient's self-care data for provision of a communication channel between the patient and a healthcare professional, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
381292
Start Date
December 23, 2021
Effective Date
December 23, 2021
Manufacturer
Country
United States of America
Address
2881 Scott Boulevard, Santa Clara, California, 95050