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Uterus-supporting pessary - ARTG 368830

Access comprehensive regulatory information for Uterus-supporting pessary in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 368830 and sponsored by Sigma Company Limited, manufactured by MedGyn Products International Inc and MedGyn Products Inc in United States of America. The device registration started on June 10, 2021.

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 368830
Class IIa
Uterus-supporting pessary
ARTG ID: 368830
Good Name: Sigma Company Limited - Uterus-supporting pessary
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Intended Purpose

This is a device that is intended to be inserted into the vagina. This device is intended to be used for mild prolapse as well as urinary incontinence also for mild first-degree prolapse and used for an accompanying cystocele. The device is also intended to be used for second- to third-degree prolapse or procidentia, a rectocele as well as being effective in the prevention of exercise incontinence in women.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
368830
Start Date
June 10, 2021
Effective Date
June 10, 2021
Manufacturer
Country
United States of America
Address
100 West Industrial Road, Addison, Illinois, 60101