SOPRO CO2 Gas Insufflator - Distension unit, gas, laparoscopic - ARTG 462491
Access comprehensive regulatory information for SOPRO CO2 Gas Insufflator - Distension unit, gas, laparoscopic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 462491 and sponsored by Erbe Australia Pty Ltd, manufactured by SOPRO A Company of ACTEON Group in France. The device registration started on September 20, 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.
This device and the associated accessories are intended to create a pneumoperitoneum (distension of the abdominal cavity) by filling with CO2 (at a temperature adapted to that of the human body) at a known pressure and flow rate according to a defined instruction, under the responsibility of the surgeon during a diagnosis or laparoscopic surgery.