Australia TGA ARTG record

Urinary-incontinence vaginal insert, reusable

Australia TGA ARTG Registered Device · B Braun Australia Pty Ltd · B Braun Medical SAS · Class IIa · Started October 10, 2017

Good Name: B Braun Australia Pty Ltd - Urinary-incontinence vaginal insert, reusable

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 10, 2017
Effective Date: October 10, 2017

Sponsor

Name: B Braun Australia Pty Ltd

Manufacturer

Name: B Braun Medical SAS
Country: France
Address: 26 Rue Armengaud, Saint-Cloud, France, 92210

Intended purpose

Intravaginal device for women suffering from stress urinary incontinence. A non-absorbent device with a removal cord and an application kit (tube and push rod).

About this record

Access comprehensive regulatory information for Urinary-incontinence vaginal insert, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by B Braun Australia Pty Ltd, manufactured by B Braun Medical SAS in France. The device registration started on October 10, 2017.

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.