Australia TGA ARTG record

Patient monitor, electrocardiograph

Australia TGA ARTG Registered Device · GE Healthcare Australia Pty Ltd · IVY Biomedical Systems Inc · Class IIb · Started March 27, 2013

Good Name: GE Healthcare Australia Pty Ltd - Patient monitor, electrocardiograph

Device classification

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

Registration information

Start Date: March 27, 2013
Effective Date: March 27, 2013

Sponsor

Name: GE Healthcare Australia Pty Ltd

Manufacturer

Name: IVY Biomedical Systems Inc
Country: United States of America
Address: 11 Business Park Drive, BRANFORD, Connecticut, 06405

Intended purpose

Cardiac trigger monitors intended primarily for use on patients in applications requiring precision R-wave synchronization.

About this record

Access comprehensive regulatory information for Patient monitor, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by GE Healthcare Australia Pty Ltd, manufactured by IVY Biomedical Systems Inc in United States of America. The device registration started on March 27, 2013.

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.