Australia TGA ARTG record

Polymeric vaginal stent, non-bioabsorbable

Australia TGA ARTG Registered Device · Profile Medical Devices Pty Ltd · Zephyr Surgical Implants · Class I · Started July 20, 2020

Good Name: Profile Medical Devices Pty Ltd- Polymeric vaginal stent, non-bioabsorbable

Device classification

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

Registration information

Start Date: July 20, 2020
Effective Date: July 20, 2020

Sponsor

Name: Profile Medical Devices Pty Ltd

Manufacturer

Name: Zephyr Surgical Implants
Country: Switzerland
Address: Route des jeunes 4 bis CH-1227 Les Acacias, Geneva

Intended purpose

The device is an inflatable vaginal stent to expand the vagina.

About this record

Access comprehensive regulatory information for Polymeric vaginal stent, non-bioabsorbable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Profile Medical Devices Pty Ltd, manufactured by Zephyr Surgical Implants in Switzerland. The device registration started on July 20, 2020.

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.