Australia TGA ARTG record

Morpheus VED systems - Penile rigidity device

Australia TGA ARTG Registered Device · MHDU Operations Pty Ltd · Reflexonic LLC · Class I · Started April 17, 2024

Good Name: MHDU Operations Pty Ltd - Morpheus VED systems - Penile rigidity device

Device classification

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

Registration information

Start Date: April 17, 2024
Effective Date: April 17, 2024

Sponsor

Name: MHDU Operations Pty Ltd

Manufacturer

Name: Reflexonic LLC
Country: United States of America
Address: 44055 Riverside Parkway Suite 208, Leesburg, Virginia

Intended purpose

The Morpheus VED System is a medical-grade vacuum erection device (penis pump) designed for men with erectile dysfunction, aiding in erection rehabilitation and improving circulation.

About this record

Access comprehensive regulatory information for Morpheus VED systems - 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 Reflexonic LLC in United States of America. The device registration started on April 17, 2024.

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.