Pure Global

Mectronic Medicale Pulswave system - Electromechanical orthopaedic extracorporeal shock wave therapy system - ARTG 459405

Access comprehensive regulatory information for Mectronic Medicale Pulswave system - Electromechanical orthopaedic extracorporeal shock wave therapy system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 459405 and sponsored by Aerobe Pty Ltd, manufactured by Mectronic Medicale SRL in Italy. The device registration started on August 13, 2024.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 459405
Class IIa
Mectronic Medicale Pulswave system - Electromechanical orthopaedic extracorporeal shock wave therapy system
ARTG ID: 459405
Good Name: Aerobe Pty Ltd - Mectronic Medicale Pulswave system - Electromechanical orthopaedic extracorporeal shock wave therapy system
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Active medical devices and accessories for temporary use, indicated for non-invasive physiotherapy and rehabilitation treatments such as: pain relief, reducing inflammation, reabsorption enhancement of edema, decontracting, tissue regeneration and biostimulation. PulsWave 2 is a device for radial extracorporeal shock wave therapy. By interacting with tissues, radial shock waves accelerate tissue regeneration and cell growth, relieving pain and restoring mobility.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
459405
Start Date
August 13, 2024
Effective Date
August 13, 2024
Sponsor
Manufacturer
Country
Italy
Address
Via Orio Al Serio 15, Grassobbio, BG, 24050