Australia flagARTG 427019

OMNISPEC MODEL ED1000 - Penile extracorporeal shock wave therapy system

ARTG ID: 427019 · Import Health Pty Ltd · Medispec Ltd · Class IIb · Started October 27, 2023

Good Name: Import Health Pty Ltd - OMNISPEC MODEL ED1000 - Penile extracorporeal shock wave therapy system

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
427019
Start Date
October 27, 2023
Effective Date
October 27, 2023
Sponsor
Manufacturer
Country
Israel
Address
40 Hataasiya St PO Box 292, Yehud, 5610103
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 Peyronie’s disease which has not sufficiently responded to conventional therapy.

About this record

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 registered under ARTG number 427019 and 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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