Australia TGA ARTG record

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Australia TGA ARTG Registered Device · Silverline Medical Pty Ltd · Rossmax Swiss GmbH · Class IIa · Started September 12, 2023

Good Name: Silverline 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: September 12, 2023
Effective Date: September 12, 2023

Sponsor

Name: Silverline Medical Pty Ltd

Manufacturer

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

Intended purpose

A portable electrically powered device designed to non-invasively measure a patient’s systolic and diastolic blood pressures and current heart rate. The device provides a visual indication of the risk of hypertension based on 1999 WHO-International Society of Hypertension Guidelines for the management of Hypertension. Increased blood pressure if left untreated can lead to arrhythmias (e.g. atrial fibrillation Afib, premature contraction PC) or non-type -specific arrhythmias providing a warning signal to the user to consult a doctor for potential diagnosis and treatment.

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 Silverline Medical Pty Ltd, manufactured by Rossmax Swiss GmbH in Switzerland. The device registration started on September 12, 2023.

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.