Australia flagARTG 459446

General/multiple surgical laser system beam guide, single-use

ARTG ID: 459446 · Uroflow Solutions Pty Ltd · Elesta SpA · Class IIa · Started August 14, 2024

Good Name: Uroflow Solutions Pty Ltd - General/multiple surgical laser system beam guide, single-use

Device classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration information
ARTG ID
459446
Start Date
August 14, 2024
Effective Date
August 14, 2024
Sponsor
Manufacturer
Country
Italy
Address
Via Baldanzese 17, Calenzano, FI, 50041
Intended purpose

The Laser Thermal Therapy Kit is intended to direct laser energy to soft tissues in image-guided endoscopic and percutaneous laser thermal ablation procedure. The energy is transmitted via the fiber optic, which is introduced into the tissue using the introducer needle.

About this record

Access comprehensive regulatory information for General/multiple surgical laser system beam guide, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 459446 and sponsored by Uroflow Solutions Pty Ltd, manufactured by Elesta SpA in Italy. The device registration started on August 14, 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.

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