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Endoscopic ligature loop

Access comprehensive regulatory information for Endoscopic ligature loop 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 Leo Medical Co Ltd in China. The device registration started on August 12, 2016.

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
Class IIa
Endoscopic ligature loop
Australia TGA ARTG Registered Device
Good Name: CK Surgitech Pty Ltd - Endoscopic ligature loop
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Intended Purpose

A device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer or suture material) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 12, 2016
Effective Date
August 12, 2016
Manufacturer
Country
China
Address
1st and 2nd Floor No 10 Building 18 Huashan Road Changzhou City, Jiangsu Province, 213022