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LUX-Dx Clinic Assistant Mobile Device - Implantable cardiac device management application software - ARTG 472725

Access comprehensive regulatory information for LUX-Dx Clinic Assistant Mobile Device - Implantable cardiac device management application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 472725 and sponsored by Boston Scientific Pty Ltd, manufactured by Cardiac Pacemakers Inc a subsidiary of Boston Scientific Corporation in United States of America. The device registration started on December 11, 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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Class III
ARTG 472725
Class III
LUX-Dx Clinic Assistant Mobile Device - Implantable cardiac device management application software
ARTG ID: 472725
Good Name: Boston Scientific Pty Ltd - LUX-Dx Clinic Assistant Mobile Device - Implantable cardiac device management application software
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Intended Purpose

Software app that is installed on non-medical off-the-shelf mobile devices and function by collecting and transmitting event, patient, and device data. It is intended for use during in-clinic follow-up sessions with patients who have an ICM device. It can also be used at insertion to view current device status and view real-time S-ECG.

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
472725
Start Date
December 11, 2024
Effective Date
December 11, 2024
Manufacturer
Country
United States of America
Address
4100 Hamline Avenue North, St Paul, Minnesota, 55112-5798