Australia TGA ARTG record

Irreversible electroporation system

Australia TGA ARTG Registered Device · Circular Medical Pty Ltd · Surgnova Healthcare Technologies (Zhejiang) Co Ltd · Class IIb · Started March 02, 2023

Good Name: Circular Medical Pty Ltd - Irreversible electroporation system

Device classification

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

Registration information

Start Date: March 02, 2023
Effective Date: March 02, 2023

Sponsor

Name: Circular Medical Pty Ltd

Manufacturer

Name: Surgnova Healthcare Technologies (Zhejiang) Co Ltd
Country: China
Address: No 1 Xingxing Yilu Road Emerging Industrial Cluster Area Zonghan Subdistrict, Cixi City, Zhejiang Province, 315301

Intended purpose

The Electroporation System is intended for surgical ablation of soft tissue (including pancreas, liver, prostate) by irreversible electroporation.The equipment is for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed.

About this record

Access comprehensive regulatory information for Irreversible electroporation system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Circular Medical Pty Ltd, manufactured by Surgnova Healthcare Technologies (Zhejiang) Co Ltd in China. The device registration started on March 02, 2023.

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.