ARTG 468946Single Use Sterile Laparoscopic Trocar System- IIa - Laparoscopic trocar/sleeve, single-use
ARTG ID: 468946 · Endovision Pty Ltd · Surgaid Medical (Xiamen) Co Ltd · Class IIa · Started November 15, 2024
Good Name: Endovision Pty Ltd - Single Use Sterile Laparoscopic Trocar System- IIa - Laparoscopic trocar/sleeve, single-use
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 468946
- Start Date
- November 15, 2024
- Effective Date
- November 15, 2024
- Country
- China
- Address
- Building 5 No 18 Shanbianhong East Road, Haicang District Xiamen City, Fujian Province, 361026
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 The trocar is intended to fill the lumen of the sleeve during insertion, and is then withdrawn once the sleeve is in situ to provide an access port to the abdominal cavity; a laparoscopic sleeve seal may be included.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.
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.
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