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Endoscopic gas distention system - ARTG 425990

Access comprehensive regulatory information for Endoscopic gas distention system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 425990 and sponsored by PlainSolution, manufactured by Chongqing Jinshan Science & Technology (Group) Co Ltd in China. The device registration started on October 18, 2023.

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 425990
Class IIa
Endoscopic gas distention system
ARTG ID: 425990
Good Name: PlainSolution - Endoscopic gas distention system
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Intended Purpose

This is an AC-powered active device used to distend (expand by pressure) the colon or the gastrointestinal (GI) tract by filling the cavity with pressure-limited carbon dioxide (CO2) gas during an endoscopic procedure which may also apply to radiography. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. It is also commonly known as an insufflator.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
425990
Start Date
October 18, 2023
Effective Date
October 18, 2023
Sponsor
Manufacturer
Country
China
Address
No 18 Nishang Road LiangLu Industrial City, Yubei District, Chongqing, 401120