Australia TGA ARTG record

Penile ring

Australia TGA ARTG Registered Device · MHDU Operations Pty Ltd · Kessel medintim GmbH · Class I · Started September 05, 2022

Good Name: MHDU Operations Pty Ltd - Penile ring

Device classification

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

Registration information

Start Date: September 05, 2022
Effective Date: September 05, 2022

Sponsor

Name: MHDU Operations Pty Ltd

Manufacturer

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

Intended purpose

A device intended to be applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for vaginal intercourse. It is typically designed as a flexible rubber loop that is placed on the penis (i.e., around its base) to restrict the flow of venous blood leaving the penis during an erection. This device can be used alone or with a penile vacuum pump. This is a reusable device.

About this record

Access comprehensive regulatory information for Penile ring in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by MHDU Operations Pty Ltd, manufactured by Kessel medintim GmbH in Germany. The device registration started on September 05, 2022.

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.