Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Medkiosk Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
321851

Public Summary

Summary for ARTG Entry:

321851

Medkiosk Pty Ltd - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medkiosk Pty Ltd

Postal Address

2 Barnes Road,Frenchs Forest, NSW, 2086

Australia

ARTG Start Date

16/08/2019

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Health & Life Co Ltd

9F No 186 Jian Yi Road

Zhonghe District, New Taipei City, 23553

Taiwan

Products

1. Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Product Type

Single Device Product

Effective date

16/08/2019

GMDN

45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Intended purpose

A hand held blood pressure monitoring device that uses the oscillometric method to automatically measure

systolic and diastolic blood pressure as well as heart beat. The measurement position is at human being's

upper arm and all values can be read out in one LCD panel on the device with memory to hold the past

readings.

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 06:46:13 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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