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Biopsy Delivery System - Electromagnetic device tracking system - ARTG 455105

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 registered under ARTG number 455105 and 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.

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Class IIb
ARTG 455105
Class IIb
Biopsy Delivery System - Electromagnetic device tracking system
ARTG ID: 455105
Good Name: Merit Medical Australia Pty Ltd - Biopsy Delivery System - Electromagnetic device tracking system
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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.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
455105
Start Date
July 11, 2024
Effective Date
July 11, 2024
Manufacturer
Country
United States of America
Address
1600 West Merit Parkway, South Jordan, UTAH, 84095