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Penile rigidity splint - ARTG 459008

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.

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Class I
ARTG 459008
Class I
Penile rigidity splint
ARTG ID: 459008
Good Name: MHDU Operations Pty Ltd - Penile rigidity splint
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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.

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
Manufacturer
Country
United States of America
Address
7440 N St Louis Ave, Skokie, IL, 60076