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Marker, lesion localization, implantable - ARTG 475865

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 475865 and sponsored by Gamma Gurus Pty Ltd, manufactured by Nanovi AS in Denmark. The device registration started on January 15, 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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Class IIb
ARTG 475865
Class IIb
Marker, lesion localization, implantable
ARTG ID: 475865
Good Name: Gamma Gurus Pty Ltd - Marker, lesion localization, implantable
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Intended Purpose

For use to radiographically mark soft tissue and is intended to mark tissue for at least 2 months after implantation.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
475865
Start Date
January 15, 2025
Effective Date
January 15, 2025
Manufacturer
Country
Denmark
Address
Diplomvej 378, Kgs Lyngby, 2800