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Electromagnetic/optical surgical navigation device tracking system - ARTG 448107

Access comprehensive regulatory information for Electromagnetic/optical surgical navigation device tracking system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 448107 and sponsored by Stryker Australia Pty Ltd, manufactured by Stryker Leibinger GmbH & Co KG in Germany. The device registration started on May 08, 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 IIa
ARTG 448107
Class IIa
Electromagnetic/optical surgical navigation device tracking system
ARTG ID: 448107
Good Name: Stryker Australia Pty Ltd - Electromagnetic/optical surgical navigation device tracking system
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Intended Purpose

Intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure can be identified.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
448107
Start Date
May 08, 2024
Effective Date
May 08, 2024
Manufacturer
Country
Germany
Address
Botzinger Strasse 41, Freiburg, 79111