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Marker, image identification, manual - ARTG 406432

Access comprehensive regulatory information for Marker, image identification, manual in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 406432 and sponsored by Adler Ortho Australia Pty Ltd, manufactured by IZI Medical Products LLC in United States of America. The device registration started on March 20, 2023.

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 Is
ARTG 406432
Class Is
Marker, image identification, manual
ARTG ID: 406432
Good Name: Adler Ortho Australia Pty Ltd - Marker, image identification, manual
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Intended Purpose

Intended to be used as an image guided surgery system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery procedures.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
406432
Start Date
March 20, 2023
Effective Date
March 20, 2023
Manufacturer
Country
United States of America
Address
5 Easter Court Suite J, Owings Mills, MD, 21117