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HiCardi+ - Physiology/motion recording wristband - ARTG 463887

Access comprehensive regulatory information for HiCardi+ - Physiology/motion recording wristband in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 463887 and sponsored by Visionflex Pty Ltd, manufactured by MEZOO Co Ltd in North Korea. The device registration started on October 08, 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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TGA ARTG Official Data
Class IIb
ARTG 463887
Class IIb
HiCardi+ - Physiology/motion recording wristband
ARTG ID: 463887
Good Name: Visionflex Pty Ltd - HiCardi+ - Physiology/motion recording wristband
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Intended Purpose

Wearable Multi-parameter Monitor and Holter System.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
463887
Start Date
October 08, 2024
Effective Date
October 08, 2024
Manufacturer
Country
North Korea
Address
808 Medical Device Complex Center Gieopdosi-ro 200, Jijeong-myeon Wonju-si, Gangwon-do, 26354