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Marker, lesion localization, implantable - ARTG 481126

Access comprehensive regulatory information for Marker, lesion localization, implantable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 481126 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Covidien llc in United States of America. The device registration started on February 27, 2025.

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 IIb
ARTG 481126
Class IIb
Marker, lesion localization, implantable
ARTG ID: 481126
Good Name: Medtronic Australasia Pty Ltd - Marker, lesion localization, implantable
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Intended Purpose

The device is intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481126
Start Date
February 27, 2025
Effective Date
February 27, 2025
Manufacturer
Country
United States of America
Address
15 Hampshire Street, Mansfield, MA, 02048