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Instrument/analyser IVDs - ARTG 386738

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 386738 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 05, 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 I
ARTG 386738
Class I
Instrument/analyser IVDs
ARTG ID: 386738
Good Name: Roche Diagnostics Australia Pty Limited - Instrument/analyser IVDs
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Intended Purpose

Instruments that are intended to be used as an IVD for the purposes of processing, examining and/or providing information about a clinical specimen

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
386738
Start Date
April 05, 2022
Effective Date
April 05, 2022
Manufacturer
Country
United States of America
Address
2881 Scott Blvd, Santa Clara, CA, 95050