Australia TGA ARTG record

Gastrointestinal endoscopic clip, long-term

Australia TGA ARTG Registered Device · C R Kennedy & Co Pty Ltd · Hangzhou AGS MedTech Co Ltd · Class IIb · Started September 22, 2021

Good Name: C R Kennedy & Co Pty Ltd - Gastrointestinal endoscopic clip, long-term

Device classification

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

Registration information

Start Date: September 22, 2021
Effective Date: September 22, 2021

Sponsor

Name: C R Kennedy & Co Pty Ltd

Manufacturer

Name: Hangzhou AGS MedTech Co Ltd
Country: China
Address: Building 5 Building 6 No 597 Kangxin Road Yuhang District Hangzhou Zhejiang, Peoples Republic of China, 311106

Intended purpose

The haemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking, 2. Haemostasis for: (1) Mucosal/sub-muscosal defects<3cm, (2) Bleeding ulcers; (3) Arteries<2mm, (4) Polyps<1.5cm in diameter, (5) Diverticula in the colon, 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. 4.As a supplementary method, closure of GI tract luminal perforations<20mm that can be treated conservatively.

About this record

Access comprehensive regulatory information for Gastrointestinal endoscopic clip, long-term in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by C R Kennedy & Co Pty Ltd, manufactured by Hangzhou AGS MedTech Co Ltd in China. The device registration started on September 22, 2021.

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.