Pure Global

Manual Erection System (MES) - Penile rigidity device

Access comprehensive regulatory information for Manual Erection System (MES) - Penile rigidity device 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 March 17, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Manual Erection System (MES) - Penile rigidity device
Australia TGA ARTG Registered Device
Good Name: MHDU Operations Pty Ltd - Manual Erection System (MES) - Penile rigidity device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Manual Erection System vacuum system is intended to artificially produce an erection in males suffering from erectile dysfunction in order to facilitate sexual intercourse

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
March 17, 2022
Effective Date
March 17, 2022
Sponsor
Manufacturer
Country
Germany
Address
Kelsterbacher Strasse 28, Moerfelden-Walldorf, 64546