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Cable/lead, electrocardiograph, radiolucent - ARTG 385310

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 registered under ARTG number 385310 and 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.

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TGA ARTG Official Data
Class I
ARTG 385310
Class I
Cable/lead, electrocardiograph, radiolucent
ARTG ID: 385310
Good Name: Global Medical Solutions Australia Pty Limited - Cable/lead, electrocardiograph, radiolucent
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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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
385310
Start Date
March 09, 2022
Effective Date
March 09, 2022
Manufacturer
Country
United States of America
Address
11705 39th Street, Coral Springs, FL, 33065