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Plasma Surgery System - Neutral plasma surgical system - ARTG 461825

Access comprehensive regulatory information for Plasma Surgery System - Neutral plasma surgical system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 461825 and sponsored by Sungo Australia Pty Ltd, manufactured by Chengdu Mechan Electronic Technology Co Ltd in China. The device registration started on September 02, 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 IIb
ARTG 461825
Class IIb
Plasma Surgery System - Neutral plasma surgical system
ARTG ID: 461825
Good Name: Sungo Australia Pty Ltd - Plasma Surgery System - Neutral plasma surgical system
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Intended Purpose

The device is intended for ablation and coagulation of soft tissues, including throat, nose, joint, ligaments and prostate etc.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
461825
Start Date
September 02, 2024
Effective Date
September 02, 2024
Manufacturer
Country
China
Address
No11 District 9 Huayin Industrial Harbor No 618 West Kelin Road Chengdu Straits, Science & Tech Industrial Development Park, Wenjiang District Chengdu