Australia TGA ARTG recordPatient data recorder, long-term, electrocardiograph
Australia TGA ARTG Registered Device · Compliance Management Solutions · Global Instrumentation LLC · Class IIb · Started December 18, 2012
Good Name: Compliance Management Solutions- Patient data recorder, long-term, electrocardiograph
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- Start Date
- December 18, 2012
- Effective Date
- December 18, 2012
- Country
- United States of America
- Address
- 7010 Fly Road Suite 5, East Syracuse, New York, 13057
Intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over periods of up to 48-hours for a minimum 24-hour period. The Holter System is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm, and arrhythmia
Access comprehensive regulatory information for Patient data recorder, long-term, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Compliance Management Solutions, manufactured by Global Instrumentation LLC in United States of America. The device registration started on December 18, 2012.
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.