Thermometer, electronic, intermittent

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

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Available from:
Australia and New Zealand Health Products Limited
Class:
Class IIa
Authorization status:
Included
Authorization number:
339574

Public Summary

Summary for ARTG Entry:

339574

Australia and New Zealand Health Products Limited - Thermometer, electronic, intermittent

ARTG entry for

Medical Device Included Class IIa

Sponsor

Australia and New Zealand Health Products Limited

Postal Address

Suite 802 Level 8 167 - 169 Queen Street, Melbourne, VIC, 3000

Australia

ARTG Start Date

15/07/2020

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

Guangdong Genial Technology Co Ltd

11 Road Area B Guangfozhao Economic

Cooperation Zone Zhagang Town Huaiji County

Zhaoqing City, Guangdong Province, 526437

China

Products

1 . Thermometer, electronic, intermittent

Product Type

Single Device Product

Effective Date

15/07/2020

GMDN

14035 Thermometer, electronic, intermittent

Intended Purpose

Measures peoples body temperatures.

Specific Conditions

No Specific Conditions included on Record

© 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 22.07.2020 at 09:06:41 AEST

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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