Australia TGA ARTG record

Penile rigidity device

Australia TGA ARTG Registered Device · Profile Medical Devices Pty Ltd · Kessel medintim GmbH · Class IIa · Started July 09, 2021

Good Name: Profile Medical Devices Pty Ltd - Penile rigidity device

Device classification

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

Registration information

Start Date: July 09, 2021
Effective Date: July 09, 2021

Sponsor

Name: Profile Medical Devices Pty Ltd

Manufacturer

Name: Kessel medintim GmbH
Country: Germany
Address: Kelsterbacher Strasse 28, Moerfelden-Walldorf, 64546

Intended purpose

The external erection system is used as an erection aid

About this record

Access comprehensive regulatory information for Penile rigidity device in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Profile Medical Devices Pty Ltd, manufactured by Kessel medintim GmbH in Germany. The device registration started on July 09, 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.