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Distension unit, gas, laparoscopic

Access comprehensive regulatory information for Distension unit, gas, laparoscopic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Circular Medical Pty Ltd, manufactured by Surgnova Healthcare Technologies (Zhejiang) Co Ltd in China. The device registration started on December 01, 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.

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Class IIa
Class IIa
Distension unit, gas, laparoscopic
Australia TGA ARTG Registered Device
Good Name: Circular Medical Pty Ltd - Distension unit, gas, laparoscopic
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DJ Fang

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Intended Purpose

The unit is designed to distend the peritoneal cavity by filling it with a pressure limited gas, normally carbon dioxide CO2. this allows the surgeon a space within the abdomen to preform surgical procedures in a safe working space. This is normally a laparoscopic procedure.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 01, 2021
Effective Date
December 01, 2021
Manufacturer
Country
China
Address
No 1 Xingxing Yilu Road Emerging Industrial Cluster Area Zonghan Subdistrict, Cixi City, Zhejiang Province, 315301