Australia TGA ARTG record

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Australia TGA ARTG Registered Device · Sefam Medical Pty Ltd · Andon Health Co Ltd · Class IIa · Started November 16, 2021

Good Name: Sefam Medical Pty Ltd - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

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

Sponsor

Name: Sefam Medical Pty Ltd

Manufacturer

Name: Andon Health Co Ltd
Country: China
Address: No 3 Jinping Street YaAn Road, Tianjin, Nankai District, 300190

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.

About this record

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.