ARTG 459008

Penile rigidity splint

ARTG ID: 459008 · MHDU Operations Pty Ltd · Global Life Technologies LLC · Class I · Started August 09, 2024

Good Name: MHDU Operations Pty Ltd - Penile rigidity splint

Device classification

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

Registration information

ARTG ID: 459008
Start Date: August 09, 2024
Effective Date: August 09, 2024

Sponsor

Name: MHDU Operations Pty Ltd

Manufacturer

Name: Global Life Technologies LLC
Country: United States of America
Address: 7440 N St Louis Ave, Skokie, IL, 60076

Intended purpose

A device intended to be worn externally on the penis of a patient affected by erectile dysfunction or premature ejaculation to support a flaccid penis during vaginal intercourse. It may also be intended to stimulate a penile erection.

About this record

Access comprehensive regulatory information for Penile rigidity splint in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 459008 and sponsored by MHDU Operations Pty Ltd, manufactured by Global Life Technologies LLC in United States of America. The device registration started on August 09, 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.