Surgical diode laser system
ARTG ID: 457689 · Uroflow Solutions Pty Ltd · EL EN SpA · Class IIb · Started July 30, 2024
Good Name: Uroflow Solutions Pty Ltd - Surgical diode laser system
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 457689
- Start Date
- July 30, 2024
- Effective Date
- July 30, 2024
- Name
- EL EN SpA
- Country
- Italy
- Address
- Via Baldanzese 17, Calenzano FI, 50041
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
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.