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Active3 Erection System - Penile rigidity device

Access comprehensive regulatory information for Active3 Erection System - Penile rigidity device in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by MHDU Operations Pty Ltd, manufactured by Kessel medintim GmbH in Germany. The device registration started on July 29, 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 IIa
Class IIa
Active3 Erection System - Penile rigidity device
Australia TGA ARTG Registered Device
Good Name: MHDU Operations Pty Ltd - Active3 Erection System - Penile rigidity device
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Intended Purpose

The Active3 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 IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 29, 2022
Effective Date
July 29, 2022
Manufacturer
Country
Germany
Address
Kelsterbacher Strasse 28, Moerfelden-Walldorf, 64546