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Balloon, intrauterine - ARTG 463987

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 463987 and sponsored by Stark Medical, manufactured by MedGyn Products International Inc and MedGyn Products Inc in United States of America. The device registration started on October 09, 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 IIa
ARTG 463987
Class IIa
Balloon, intrauterine
ARTG ID: 463987
Good Name: Stark Medical - Balloon, intrauterine
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Intended Purpose

Intended to provide tamponade for controlling haemorrhage after vaginal or caesarean delivery. By applying pressure, it helps reduce postpartum bleeding. It may include an additional balloon that can be inflated in the upper vagina to seal the uterine cavity. This is a single use device

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
463987
Start Date
October 09, 2024
Effective Date
October 09, 2024
Sponsor
Manufacturer
Country
United States of America
Address
100 West Industrial Road, Addison, Illinois, 60101