Thermometer, electronic, intermittent

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

Buy It Now

Available from:
IGC Dorel Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322985

Public Summary

Summary for ARTG Entry:

322985

IGC Dorel Pty Ltd - Thermometer, electronic, intermittent

ARTG entry for

Medical Device Included Class IIa

Sponsor

IGC Dorel Pty Ltd

Postal Address

655-685 Somerville Road,SUNSHINE WEST, VIC, 3020

Australia

ARTG Start Date

11/09/2019

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

Microlife Corporation

9F 431 Ruiguang Road

Nei Hu, Taipei, 11492

Taiwan

Products

1. Thermometer, electronic, intermittent

Product Type

Single Device Product

Effective date

11/09/2019

GMDN

14035 Thermometer, electronic, intermittent

Intended purpose

A measuring device for determining the patient's body temperature. It comprises an electronic unit and an

attached sensor that detects and converts the changes in temperature into variations of some electrical

characteristic, e.g. resistance or voltage. These variations of the electric characteristics are processed in

the electronic circuits and in turn displayed as temperature readings. This device group includes electronic

thermometers for periodic or continuous temperature measurement

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 04:34:58 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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