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Ultrasonic surgical system generator - ARTG 484186

Access comprehensive regulatory information for Ultrasonic surgical system generator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 484186 and sponsored by Ascend Surgical and Medical, manufactured by BJZHF Panther Medical Equipment Co Ltd in China. The device registration started on March 26, 2025.

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
ARTG 484186
Class IIb
Ultrasonic surgical system generator
ARTG ID: 484186
Good Name: Ascend Surgical and Medical - Ultrasonic surgical system generator
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DJ Fang

DJ Fang

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Intended Purpose

This system is indicated for soft tissue cutting when bleeding control and minimal thermal injury is desired. It is also indicated for general, gynecologic in open and Laparoscopic surgery. It cannot be used for the blood vessel with close diameter more than 3mm alone. The product is not applicable to bone removal, dental, tubal ligation and neurosurgery.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
484186
Start Date
March 26, 2025
Effective Date
March 26, 2025
Manufacturer
Country
China
Address
No 8 Shangcheng Road Beiqijia, Changping District, Beijing, 102209