Pure Global

Single Use Sterile Laparoscopic Trocar System- IIa - Laparoscopic trocar/sleeve, single-use - ARTG 468946

Access comprehensive regulatory information for Single Use Sterile Laparoscopic Trocar System- IIa - Laparoscopic trocar/sleeve, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 468946 and sponsored by Endovision Pty Ltd, manufactured by Surgaid Medical (Xiamen) Co Ltd in China. The device registration started on November 15, 2024.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 468946
Class IIa
Single Use Sterile Laparoscopic Trocar System- IIa - Laparoscopic trocar/sleeve, single-use
ARTG ID: 468946
Good Name: Endovision Pty Ltd - Single Use Sterile Laparoscopic Trocar System- IIa - Laparoscopic trocar/sleeve, single-use
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A sterile, surgical device assembly that includes a single-lumen sleeve (laparoscopic sleeve) and a sharp rigid intraluminal rod/pin/blade (laparoscopic trocar), intended to puncture the abdominal wall and create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The trocar is intended to fill the lumen of the sleeve during insertion, and is then withdrawn once the sleeve is in situ to provide an access port to the abdominal cavity; a laparoscopic sleeve seal may be included. It is available in a variety of dimensions and/or designs. May include an attached accessory, Laparoscopic Filter to remove Surgical Smoke. Filter will include a activated Charcoal filter and ULPA filter. This is system is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
468946
Start Date
November 15, 2024
Effective Date
November 15, 2024
Manufacturer
Country
China
Address
Building 5 No 18 Shanbianhong East Road, Haicang District Xiamen City, Fujian Province, 361026