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External lesion localization marker, single-use - ARTG 325303

Access comprehensive regulatory information for External lesion localization marker, 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 325303 and sponsored by Zimmer Biomet Pty Ltd, manufactured by Northern Digital Inc in Canada. The device registration started on October 22, 2019.

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 325303
Class Is
External lesion localization marker, single-use
ARTG ID: 325303
Good Name: Zimmer Biomet Pty Ltd - External lesion localization marker, single-use
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Intended Purpose

Disposable markers for use as an accessory during surgical navigation in image guided surgery.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
325303
Start Date
October 22, 2019
Effective Date
October 22, 2019
Manufacturer
Country
Canada
Address
103 Randall Drive, Waterloo, Ontario, N2V 1C5