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Morcellator System - Tissue morcellation system

Access comprehensive regulatory information for Morcellator System - Tissue morcellation system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Actis Medical Pty Ltd, manufactured by Hangzhou Hawk Optical Electronic Instruments Co Ltd in China. The device registration started on January 24, 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.

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Class IIa
Class IIa
Morcellator System - Tissue morcellation system
Australia TGA ARTG Registered Device
Good Name: Actis Medical Pty Ltd - Morcellator System - Tissue morcellation system
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Intended Purpose

An assembly of devices used to mechanically cut and extract (ie. shave) selected tissue from the body during laparoscopic surgery. The system consists of a rotating blade and holder for tissue resection and extraction, and a mains-powered control unit that drives the blade. The system can also provide suction intended for removal of resected tissue.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
January 24, 2024
Effective Date
January 24, 2024
Manufacturer
Country
China
Address
9 Xinda Road Suoqian Xiaoshan, Hangzhou, Zhejiang, 311201