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Software IVDs - ARTG 447050

Access comprehensive regulatory information for Software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 447050 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Sequencing Solutions Inc in United States of America. The device registration started on April 29, 2024.

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 I
ARTG 447050
Class I
Software IVDs
ARTG ID: 447050
Good Name: Roche Diagnostics Australia Pty Limited - Software IVDs
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Intended Purpose

Software that is supplied separately intended to operate or influence an IVD instrument/analyser

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
447050
Start Date
April 29, 2024
Effective Date
April 29, 2024
Manufacturer
Country
United States of America
Address
2821 Scott Boulevard, Santa Clara, California, 95050