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Regent™ Mechanical Heart Valve with FlexCuff™ - Aortic bi-leaflet mechanical heart valve prosthesis - ARTG 482606

Access comprehensive regulatory information for Regent™ Mechanical Heart Valve with FlexCuff™ - Aortic bi-leaflet mechanical heart valve prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 482606 and sponsored by Abbott Medical Australia Pty Ltd, manufactured by Abbott Medical in United States of America. The device registration started on March 14, 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 III
ARTG 482606
Class III
Regent™ Mechanical Heart Valve with FlexCuff™ - Aortic bi-leaflet mechanical heart valve prosthesis
ARTG ID: 482606
Good Name: Abbott Medical Australia Pty Ltd - Regent™ Mechanical Heart Valve with FlexCuff™ - Aortic bi-leaflet mechanical heart valve prosthesis
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Intended Purpose

The Regent™ Mechanical Heart Valve is intended to replace native aortic heart valves or previously implanted aortic prosthetic valves.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482606
Start Date
March 14, 2025
Effective Date
March 14, 2025
Manufacturer
Country
United States of America
Address
177 County Road B East, St Paul, Minnesota, 55117