Australia TGA ARTG record

Zephyr Penile Implant - Prosthesis, internal, penile, inflatable

Australia TGA ARTG Registered Device · Profile Medical Devices Pty Ltd · Zephyr Surgical Implants · Class IIb · Started July 24, 2019

Good Name: Profile Medical Devices Pty Ltd - Zephyr Penile Implant - Prosthesis, internal, penile, inflatable

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: July 24, 2019
Effective Date: July 24, 2019

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 penile implant is a prosthesis designed to facilitate penile rigidity in patients with erectile dysfunction.

About this record

Access comprehensive regulatory information for Zephyr Penile Implant - Prosthesis, internal, penile, inflatable 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 July 24, 2019.

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.