Australia TGA ARTG record

Prosthesis, internal, urethral, sphincter

Australia TGA ARTG Registered Device · Profile Medical Devices Pty Ltd · Zephyr Surgical Implants · Class IIb · Started September 27, 2013

Good Name: Profile Medical Devices Pty Ltd - Prosthesis, internal, urethral, sphincter

Device classification

Risk Class: Class IIb
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: September 27, 2013
Effective Date: September 27, 2013

Sponsor

Name: Profile Medical Devices Pty Ltd

Manufacturer

Name: Zephyr Surgical Implants
Country: Switzerland
Address: Rue du Conseil-General 14, Geneve, CH-1205

Intended purpose

Internal Urethral Sphincter for the Treatment of Urinary Incontinence

About this record

Access comprehensive regulatory information for Prosthesis, internal, urethral, sphincter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Profile Medical Devices Pty Ltd, manufactured by Zephyr Surgical Implants in Switzerland. The device registration started on September 27, 2013.

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.