Pure Global

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist - ARTG 455925

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 registered under ARTG number 455925 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 455925
Class IIa
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
ARTG ID: 455925
Good Name: Aero Healthcare - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
455925
Start Date
July 22, 2024
Effective Date
July 22, 2024
Sponsor
Manufacturer
Country
Switzerland
Address
Widnauerstrasse 1, Heerbrugg, CH-9435