Pure Global

Surgical diode laser system - ARTG 457689

Access comprehensive regulatory information for Surgical diode laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 457689 and sponsored by Uroflow Solutions Pty Ltd, manufactured by EL EN SpA in Italy. The device registration started on July 30, 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 IIb
ARTG 457689
Class IIb
Surgical diode laser system
ARTG ID: 457689
Good Name: Uroflow Solutions Pty Ltd - Surgical diode laser system
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Echolaser X4 is a medical device intended for thermal ablation (debulking or complete destruction) of soft tissues in endoscopic and percutaneous procedures, with the following indications: 1. Debulking of tissue mass: a. Application on benign pathologies b. Application on malignant pathologies 2. Complete ablation of tissue mass (complete destruction): a. Application on benign pathologies b. Application on malignant pathologies

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
457689
Start Date
July 30, 2024
Effective Date
July 30, 2024
Manufacturer
Country
Italy
Address
Via Baldanzese 17, Calenzano FI, 50041