Australia TGA ARTG record

Upper Arm Electronic Blood Pressure Monitor - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Australia TGA ARTG Registered Device · OneX Medical Australia Pty Ltd · Shenzhen Finicare Co Ltd · Class IIa · Started July 16, 2024

Good Name: OneX Medical Australia Pty Ltd - Upper Arm Electronic Blood Pressure Monitor - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: July 16, 2024
Effective Date: July 16, 2024

Sponsor

Name: OneX Medical Australia Pty Ltd

Manufacturer

Name: Shenzhen Finicare Co Ltd
Country: China
Address: 201 No 50 the 3rd Industrial Park, Houting Community Shajing Street, Bao'an District, Shenzhen, 518104

Intended purpose

The Upper Arm Blood Pressure Monitor is intended used to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Classification (MDR, Annex VIII): Class IIa, Rule 10.

About this record

Access comprehensive regulatory information for Upper Arm Electronic Blood Pressure Monitor - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by OneX Medical Australia Pty Ltd, manufactured by Shenzhen Finicare Co Ltd in China. The device registration started on July 16, 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.