Australia TGA ARTG record

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Australia TGA ARTG Registered Device · Boian Surgical Pty Ltd · Shenzhen Combei Technology Co Ltd · Class IIa · Started September 19, 2018

Good Name: Boian Surgical 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: September 19, 2018
Effective Date: September 19, 2018

Sponsor

Name: Boian Surgical Pty Ltd

Manufacturer

Name: Shenzhen Combei Technology Co Ltd
Country: China
Address: 11-5B No 105 Huanguan South Rd Dahe Community, Guanlan Longhua New District, Shenzhen, Guangdong, 518110

Intended purpose

A digital device designed to non-invasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles.

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 Boian Surgical Pty Ltd, manufactured by Shenzhen Combei Technology Co Ltd in China. The device registration started on September 19, 2018.

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.