Australia TGA ARTG record

Surgical procedure kit, orthopaedic, single-use, non-medicated

Australia TGA ARTG Registered Device · Actis Medical Pty Ltd · CANWELL MEDICAL CO LTD · Class IIa · Started July 06, 2023

Good Name: Actis Medical Pty Ltd - Surgical procedure kit, orthopaedic, single-use, non-medicated

Device classification

Risk Class: Class IIa
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: July 06, 2023
Effective Date: July 06, 2023

Sponsor

Name: Actis Medical Pty Ltd

Manufacturer

Name: CANWELL MEDICAL CO LTD
Country: China
Address: No 466 South Xianhua Street High-Tech Industrial Zone Jinhua, Zhejiang, 321016

Intended purpose

The single-use surgical instruments are necessary to perform surgical procedures including osteosynthesis and kyphoplasty. Guidewires and drills are used to prepare bones and facilitate the implantation of orthopaedic plate systems, intramedullary nailing systems, spinal fixation systems and kyphoplasty procedures.

About this record

Access comprehensive regulatory information for Surgical procedure kit, orthopaedic, single-use, non-medicated 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 CANWELL MEDICAL CO LTD in China. The device registration started on July 06, 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.