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Blood Pressure Monitor U82RH - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist - ARTG 387551

Access comprehensive regulatory information for Blood Pressure Monitor U82RH - 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 registered under ARTG number 387551 and sponsored by Frontida Health, manufactured by Shenzhen Urion Technology Co Ltd in China. The device registration started on April 27, 2022.

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 387551
Class IIa
Blood Pressure Monitor U82RH - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
ARTG ID: 387551
Good Name: Frontida Health - Blood Pressure Monitor U82RH - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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Intended Purpose

An automatic blood pressure monitor intended to measure the systolic pressure, diastolic pressure and pulse rate through the upper arm. It is expected to be used at home, or a hospital and intended for anyone 12 years or older.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
387551
Start Date
April 27, 2022
Effective Date
April 27, 2022
Sponsor
Manufacturer
Country
China
Address
Floor 4-6th of Building D Jiale Science & Technology Industrial Zone, No 3 ChangWei Road Heshuikou Community MaTian Street, GuangMing New District, Shenzhen, 518106