Australia TGA ARTG record

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Australia TGA ARTG Registered Device · Aero Healthcare · Rossmax Swiss GmbH · Class IIa · Started July 22, 2024

Good Name: Aero Healthcare - 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: July 22, 2024
Effective Date: July 22, 2024

Sponsor

Name: Aero Healthcare

Manufacturer

Name: Rossmax Swiss GmbH
Country: Switzerland
Address: Widnauerstrasse 1, Heerbrugg, CH-9435

Intended purpose

A battery-powered device designed to noninvasively measure systolic and diastolic blood pressure, pulse rate, detection of pulse arrhythmia, atrial fibrillation (AFib), Atrial and/or Ventricular Premature Contractions (PC) using a self-contained software program that regulates automatic arm cuff inflation and measurement cycles. It is intended to be used by adult/patient consumers and not to be used on infants or neonates. This device is designed to be portable and is often used for emergency services or home blood pressure monitoring.

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 Aero Healthcare, manufactured by Rossmax Swiss GmbH in Switzerland. The device registration started on July 22, 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.