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Penile extracorporeal shock wave therapy system

Access comprehensive regulatory information for Penile extracorporeal shock wave therapy system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Alma Lasers Australia Pty Ltd, manufactured by Medispec Ltd in Israel. The device registration started on December 20, 2023.

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 IIb
Class IIb
Penile extracorporeal shock wave therapy system
Australia TGA ARTG Registered Device
Good Name: Alma Lasers Australia Pty Ltd - Penile extracorporeal shock wave therapy system
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Intended Purpose

Extracorporeal shockwave therapy system to treat erectile dysfunction in the penis.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
December 20, 2023
Effective Date
December 20, 2023
Manufacturer
Country
Israel
Address
40 Hataasiya St PO Box 292, Yehud, 5610103