Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)

01-11-2019

可用日期:
3P Pty Ltd
类:
Class IIa
授权状态:
Included
授权号:
322761

Public Summary

Summary for ARTG Entry:

322761

3P Pty Ltd - Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

ARTG entry for

Medical Device Included Class IIa

Sponsor

3P Pty Ltd

Postal Address

PO Box 114,WICKHAM, NSW, 2293

Australia

ARTG Start Date

6/09/2019

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

JOYTECH Healthcare Co Ltd

No 365 Wuzhou Road Yuhang Economic

Development Zone

Hangzhou City, Zhejiang, 311100

China

Products

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

Product Type

Single Device Product

Effective date

6/09/2019

GMDN

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

Intended purpose

A battery powered device, designed to non-invasively measure blood pressure using a self-contained

software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays

current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures.

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 05:02:26 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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