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Endoscopic electrosurgical electrode, monopolar, single-use - ARTG 463708

Access comprehensive regulatory information for Endoscopic electrosurgical electrode, monopolar, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 463708 and sponsored by PlainSolution, manufactured by Jiangsu Vedkang Medical Science & Technology Co Ltd in China. The device registration started on October 04, 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 463708
Class IIb
Endoscopic electrosurgical electrode, monopolar, single-use
ARTG ID: 463708
Good Name: PlainSolution - Endoscopic electrosurgical electrode, monopolar, single-use
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DJ Fang

DJ Fang

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Intended Purpose

It is a sterile, invasive, distal component of an electrosurgical system intended to be connected to a separate controller to deliver electrosurgical current in a monopolar configuration to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is a long thin device which has no controls and is available in a variety of forms. It is a singe-use device

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
463708
Start Date
October 04, 2024
Effective Date
October 04, 2024
Sponsor
Manufacturer
Country
China
Address
No 52 Guoxiang Road Wujin Economic Development Zone, Changzhou Jiangsu, 213149