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TFL drive system - Urogenital surgical laser system beam guide, single-use - ARTG 464585

Access comprehensive regulatory information for TFL drive system - Urogenital 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 464585 and sponsored by Coloplast Pty Ltd, manufactured by Quanta System SPA in Italy. The device registration started on October 15, 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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Class IIa
ARTG 464585
Class IIa
TFL drive system - Urogenital surgical laser system beam guide, single-use
ARTG ID: 464585
Good Name: Coloplast Pty Ltd - TFL drive system - Urogenital surgical laser system beam guide, single-use
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Intended Purpose

Optical Fiber is intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser as per the indications of the laser device used with.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
464585
Start Date
October 15, 2024
Effective Date
October 15, 2024
Manufacturer
Country
Italy
Address
Via Acquedotto 109, Samarate, VA, 21017