Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)
Veřejná zpráva o hodnocení
(PAR) 01-11-2019
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- Dostupné s:
- 3P Pty Ltd
- Třída:
- Class IIa
- Stav Autorizace:
- Included
- Registrační číslo:
- 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
