Australia TGA ARTG record

Intramedullary Nail System - Fixation device, internal, nail, intramedullary, femur

Australia TGA ARTG Registered Device · Actis Medical Pty Ltd · CANWELL MEDICAL CO LTD · Class IIb · Started August 03, 2023

Good Name: Actis Medical Pty Ltd - Intramedullary Nail System - Fixation device, internal, nail, intramedullary, femur

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: August 03, 2023
Effective Date: August 03, 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

A system of orthopaedic devices intended to be used for the intramedullary fixation of fractures in the femur.

About this record

Access comprehensive regulatory information for Intramedullary Nail System - Fixation device, internal, nail, intramedullary, femur in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Actis Medical Pty Ltd, manufactured by CANWELL MEDICAL CO LTD in China. The device registration started on August 03, 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.