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Ultrasonic Surgical Mechanical system - Electrosurgical system, ultrasonic/mechanical vibration

Access comprehensive regulatory information for Ultrasonic Surgical Mechanical system - Electrosurgical system, ultrasonic/mechanical vibration 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 December 14, 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 IIb
Class IIb
Ultrasonic Surgical Mechanical system - Electrosurgical system, ultrasonic/mechanical vibration
Australia TGA ARTG Registered Device
Good Name: Circular Medical Pty Ltd - Ultrasonic Surgical Mechanical system - Electrosurgical system, ultrasonic/mechanical vibration
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Intended Purpose

The Ultrasonic Scalpel System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures and other procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter while using the power level 1.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
December 14, 2021
Effective Date
December 14, 2021
Manufacturer
Country
China
Address
No 1 Xingxing Yilu Road Emerging Industrial Cluster Area Zonghan Subdistrict, Cixi City, Zhejiang Province, 315301