Australia TGA ARTG record

Laparoscopic clip applier

Australia TGA ARTG Registered Device · Koala Medical Pty Ltd · Taiwan Surgical Corporation · Class IIb · Started December 02, 2020

Good Name: Koala Medical Pty Ltd - Laparoscopic clip applier

Device classification

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

Registration information

Start Date: December 02, 2020
Effective Date: December 02, 2020

Sponsor

Name: Koala Medical Pty Ltd

Manufacturer

Name: Taiwan Surgical Corporation
Country: Taiwan
Address: 3F No 12 Sec 2 Sheng Yi Road, Zhubei City, Hsinchu County Taiwan, 30261

Intended purpose

A sterile, rigid, laparoscopic device designed to perform through a compatible laparoscopic instrument (e.g., an access port or a trocar sleeve) for the application of haemostatic clips to achieve occlusion of vessels and other tubular structures, and tissue following transection, as well as for radiographic marking via the abdominal cavity. It typically consists of an insertion sheath, a mechanism at the distal end for applying the clips, an integral cassette containing the surgical or ligation clips and a control handle at the proximal end for firing the clips into the target tissue. This is a single-use device.

About this record

Access comprehensive regulatory information for Laparoscopic clip applier in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Koala Medical Pty Ltd, manufactured by Taiwan Surgical Corporation in Taiwan. The device registration started on December 02, 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.