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Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Australia TGA ARTG Registered Device
Good Name: Silverline Medical Pty Ltd - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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Intended Purpose

A portable electrically powered device designed to non-invasively measure a patientโ€™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.

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
Manufacturer
Country
Switzerland
Address
Widnauerstrasse 1, Heerbrugg, CH-9435