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Spark-gap lithotripsy system

Access comprehensive regulatory information for Spark-gap lithotripsy system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Innovative Medical Technologies Pty Ltd, manufactured by Medispec Ltd in Israel. The device registration started on July 13, 2020.

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
Spark-gap lithotripsy system
Australia TGA ARTG Registered Device
Good Name: Innovative Medical Technologies Pty Ltd - Spark-gap lithotripsy system
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Intended Purpose

This is a extracorporeal shock wave lithotripsy (ESWL) device that is intended to be used to treat renal & ureter calculi by disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts as diagnosed for removal.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 13, 2020
Effective Date
July 13, 2020
Manufacturer
Country
Israel
Address
40 Hataasiya St PO Box 292, Yehud, 5610103