Australia TGA ARTG record

Electrocardiographic lead, single-use

Australia TGA ARTG Registered Device · Cardinal Health Australia 503 Pty Ltd · Cardinal Health 200 LLC · Class I · Started June 11, 2024

Good Name: Cardinal Health Australia 503 Pty Ltd - Electrocardiographic lead, single-use

Device classification

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

Registration information

Start Date: June 11, 2024
Effective Date: June 11, 2024

Sponsor

Name: Cardinal Health Australia 503 Pty Ltd

Manufacturer

Name: Cardinal Health 200 LLC
Country: United States of America
Address: 3651 Birchwood Drive, Waukegan, Illinois, 60085

Intended purpose

Provide transmission of electrocardiogram (ECG) signals from patient electrodes to ECG monitoring devices such as an ECG monitor or telemetry monitor/transmitter. Some models additionally transmit SpO2 and/or temperature signals from patient sensors to a monitor.

About this record

Access comprehensive regulatory information for Electrocardiographic lead, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Cardinal Health Australia 503 Pty Ltd, manufactured by Cardinal Health 200 LLC in United States of America. The device registration started on June 11, 2024.

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.