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
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 427019
- Start Date
- October 27, 2023
- Effective Date
- October 27, 2023
- Name
- Medispec Ltd
- Country
- Israel
- Address
- 40 Hataasiya St PO Box 292, Yehud, 5610103
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.
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.
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