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OMNISPEC MODEL ED1000 - Penile extracorporeal shock wave therapy system

Access comprehensive regulatory information for OMNISPEC MODEL ED1000 - 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 Import Health Pty Ltd, manufactured by Medispec Ltd in Israel. The device registration started on October 27, 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
OMNISPEC MODEL ED1000 - Penile extracorporeal shock wave therapy system
Australia TGA ARTG Registered Device
Good Name: Import Health Pty Ltd - OMNISPEC MODEL ED1000 - Penile extracorporeal shock wave therapy system
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Intended Purpose

Alternative/complement treatment of patients with vascular related Erectile Dysfunction (ED). Treatment of men suffering from Chronic Pelvic Pain Syndrome (CPPS). Treatment of chronic Peyronieโ€™s disease which has not sufficiently responded to conventional therapy.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 27, 2023
Effective Date
October 27, 2023
Manufacturer
Country
Israel
Address
40 Hataasiya St PO Box 292, Yehud, 5610103