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Penile ring - ARTG 395491

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 registered under ARTG number 395491 and 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.

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Class I
ARTG 395491
Class I
Penile ring
ARTG ID: 395491
Good Name: MHDU Operations Pty Ltd - Penile ring
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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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
395491
Start Date
September 05, 2022
Effective Date
September 05, 2022
Manufacturer
Country
Germany
Address
Kelsterbacher Strasse 28, Moerfelden-Walldorf, 64546