Australia TGA ARTG record

Cable/lead, electrocardiograph, radiolucent

Australia TGA ARTG Registered Device · Global Medical Solutions Australia Pty Limited · Advantage Medical Electronics dba AMC · Class I · Started March 09, 2022

Good Name: Global Medical Solutions Australia Pty Limited - Cable/lead, electrocardiograph, radiolucent

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 09, 2022
Effective Date: March 09, 2022

Sponsor

Name: Global Medical Solutions Australia Pty Limited

Manufacturer

Name: Advantage Medical Electronics dba AMC
Country: United States of America
Address: 11705 39th Street, Coral Springs, FL, 33065

Intended purpose

Radiolucent leadwires are intended for use in X-ray imaging environments, to connect electrodes placed at appropriate sites on the patient to an ECG/EKG device for general monitoring and/or diagnostic evaluation by a healthcare professional. Be sure to read and follow all the instructions that come with the IVY Biomedical monitor.

About this record

Access comprehensive regulatory information for Cable/lead, electrocardiograph, radiolucent in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Global Medical Solutions Australia Pty Limited, manufactured by Advantage Medical Electronics dba AMC in United States of America. The device registration started on March 09, 2022.

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.