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SmartXide Tetra PRO - General/multiple surgical carbon dioxide laser system - ARTG 481446

Access comprehensive regulatory information for SmartXide Tetra PRO - General/multiple surgical carbon dioxide 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 481446 and sponsored by High Tech Medical Pty Ltd, manufactured by Deka M E L A Srl in Italy. The device registration started on March 03, 2025.

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
ARTG 481446
Class IIb
SmartXide Tetra PRO - General/multiple surgical carbon dioxide laser system
ARTG ID: 481446
Good Name: High Tech Medical Pty Ltd - SmartXide Tetra PRO - General/multiple surgical carbon dioxide laser system
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Intended Purpose

The Medical laser is used for incision, excision, ablation, vaporization and coagulation of body soft tissues in Dermatology and Surgery. The scanner is used in conjunction with the medical laser for incision, excision, ablation, vaporization and coagulation of body soft tissues.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
481446
Start Date
March 03, 2025
Effective Date
March 03, 2025
Manufacturer
Country
Italy
Address
Via Baldanzese 17, Calenzano FI, Italy, 50041