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Endotherapy forceps, biopsy, flexible, single-use

Australia TGA ARTG Registered Device · CK Surgitech Pty Ltd · Hangzhou AGS MedTech Co Ltd · Class IIa · Started July 30, 2019

Good Name: CK Surgitech Pty Ltd - Endotherapy forceps, biopsy, flexible, single-use

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
July 30, 2019
Effective Date
July 30, 2019
Sponsor
Manufacturer
Country
China
Address
Building 6 Kangxin Road No. 597 Qianjiang Economic Development Area, Hangzhou, Zhejiang, 311106
Intended purpose

A flexible endoscopic instrument intended to be used to perform through a compatible endoscope, e.g., a bronchoscope. It is used to obtain specimens for histological/pathological diagnosis during endoscopy. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissor-like cups with a cutting edge around their rim which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

About this record

Access comprehensive regulatory information for Endotherapy forceps, biopsy, flexible, single-use 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 Hangzhou AGS MedTech Co Ltd in China. The device registration started on July 30, 2019.

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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