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Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Access comprehensive regulatory information for 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 Sefam Medical Pty Ltd, manufactured by Andon Health Co Ltd in China. The device registration started on November 16, 2021.

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 IIa
Class IIa
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Australia TGA ARTG Registered Device
Good Name: Sefam Medical Pty Ltd - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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Intended Purpose

For use by medical professionals or at home and as a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 16, 2021
Effective Date
November 16, 2021
Manufacturer
Country
China
Address
No 3 Jinping Street YaAn Road, Tianjin, Nankai District, 300190