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Surgical diode laser system

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 sponsored by AMALGAMATED INSTRUMENT GROUP PTY LTD, manufactured by EL EN SpA in Italy. The device registration started on February 17, 2020.

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 IIb
Class IIb
Surgical diode laser system
Australia TGA ARTG Registered Device
Good Name: AMALGAMATED INSTRUMENT GROUP PTY LTD - Surgical diode laser system
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Intended Purpose

medical device intended for thermal ablation of soft tissues in intraoperative and percutaneous procedures.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 17, 2020
Effective Date
February 17, 2020
Sponsor
Manufacturer
Country
Italy
Address
Via Baldanzese 17, Calenzano FI, 50041