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Optical surgical navigation device tracking system spatial register, single-use - ARTG 467045

Access comprehensive regulatory information for Optical surgical navigation device tracking system spatial register, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 467045 and sponsored by Amplitude Australia Pty Ltd, manufactured by Northern Digital Inc in Canada. The device registration started on November 04, 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 Is
ARTG 467045
Class Is
Optical surgical navigation device tracking system spatial register, single-use
ARTG ID: 467045
Good Name: Amplitude Australia Pty Ltd - Optical surgical navigation device tracking system spatial register, single-use
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Intended Purpose

A navigation marker used as an accessory to aid in the auto-registration and localisation during computer-assisted surgery.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
467045
Start Date
November 04, 2024
Effective Date
November 04, 2024
Manufacturer
Country
Canada
Address
103 Randall Drive, Waterloo, Ontario, N2V 1C5