Australia TGA ARTG record

Endoscopic insufflation tubing set

Australia TGA ARTG Registered Device · CK Surgitech Pty Ltd · Changzhou Endoclean Medical Device Co Ltd · Class IIa · Started May 17, 2020

Good Name: CK Surgitech Pty Ltd - Endoscopic insufflation tubing set

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 17, 2020
Effective Date: May 17, 2020

Sponsor

Name: CK Surgitech Pty Ltd

Manufacturer

Name: Changzhou Endoclean Medical Device Co Ltd
Country: China
Address: West Side of 4th Floor Building E2 West Taihu Medical Industry Incubator Park, No 9 Changyang Road Wujin District, Changzhou City, Jiangsu Province, 213000

Intended purpose

A collection of sterile flexible tubing intended to be used as a conduit to deliver medical gases [e.g., carbon dioxide (CO2), medical air] from it source to the air/water channel of an endoscope for insufflation during an endoscopic procedure. It includes synthetic polymer tubing, filters and associated connectors; it may also be intended for endoscopic lens drying, or delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

About this record

Access comprehensive regulatory information for Endoscopic insufflation tubing set in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by CK Surgitech Pty Ltd, manufactured by Changzhou Endoclean Medical Device Co Ltd in China. The device registration started on May 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.