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Z-Med II-X - Catheter, valvuloplasty, balloon dilatation - ARTG 235100

Access comprehensive regulatory information for Z-Med II-X - Catheter, valvuloplasty, balloon dilatation in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 235100 and sponsored by Intervene Medical Pty Ltd, manufactured by Numed Inc in United States of America. The device registration started on March 17, 2015.

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 235100
Class III
Z-Med II-X - Catheter, valvuloplasty, balloon dilatation
ARTG ID: 235100
Good Name: Intervene Medical Pty Ltd- Z-Med II-X - Catheter, valvuloplasty, balloon dilatation
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Intended Purpose

For Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in patients with isolated pulmonary stenosis and in patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
235100
Start Date
March 17, 2015
Effective Date
March 17, 2015
Manufacturer
Country
United States of America
Address
2880 Main Street, HOPKINTON , New York, 12965