Australia TGA ARTG record

Biopsy Delivery System - Electromagnetic device tracking system

Australia TGA ARTG Registered Device · Merit Medical Australia Pty Ltd · Merit Medical Systems Inc · Class IIb · Started July 11, 2024

Good Name: Merit Medical Australia Pty Ltd - Biopsy Delivery System - Electromagnetic device tracking system

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: July 11, 2024
Effective Date: July 11, 2024

Sponsor

Name: Merit Medical Australia Pty Ltd

Manufacturer

Name: Merit Medical Systems Inc
Country: United States of America
Address: 1600 West Merit Parkway, South Jordan, UTAH, 84095

Intended purpose

The delivery system is intended to place a reflector device percutaneously in soft tissue to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging or non-imaging guidance the reflector is intended to be located and surgically removed with the target tissue.

About this record

Access comprehensive regulatory information for Biopsy Delivery System - Electromagnetic device tracking system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Merit Medical Australia Pty Ltd, manufactured by Merit Medical Systems Inc in United States of America. The device registration started on July 11, 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.