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Balloon, intrauterine - ARTG 466085

Access comprehensive regulatory information for Balloon, intrauterine in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 466085 and sponsored by McFarlane Medical Equipment (Holdings) Pty Ltd, manufactured by MedGyn Products International Inc and MedGyn Products Inc in United States of America. The device registration started on October 28, 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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TGA ARTG Official Data
Class IIa
ARTG 466085
Class IIa
Balloon, intrauterine
ARTG ID: 466085
Good Name: McFarlane Medical Equipment (Holdings) Pty Ltd - Balloon, intrauterine
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Intended Purpose

A device to provide tamponade to control haemorrhaging from the uterus and vagina after giving birth.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
466085
Start Date
October 28, 2024
Effective Date
October 28, 2024
Manufacturer
Country
United States of America
Address
100 West Industrial Road, Addison, Illinois, 60101