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V300 Holter Monitor - Patient data recorder, long-term, electrocardiograph - ARTG 460514

Access comprehensive regulatory information for V300 Holter Monitor - Patient data recorder, long-term, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 460514 and sponsored by Ironbark Creek Investments, manufactured by VectraCor Inc in United States of America. The device registration started on August 23, 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.

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Class IIa
ARTG 460514
Class IIa
V300 Holter Monitor - Patient data recorder, long-term, electrocardiograph
ARTG ID: 460514
Good Name: Ironbark Creek Investments - V300 Holter Monitor - Patient data recorder, long-term, electrocardiograph
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Intended Purpose

Intended to record continuous data for up to 120 hours (7 days) for the detection of arrhythmias in ambulatory patients.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460514
Start Date
August 23, 2024
Effective Date
August 23, 2024
Manufacturer
Country
United States of America
Address
785 Totowa Road Suite 100, Totowa, NJ, 07512