Thermometer

Main information

  • Trade name:
  • Thermometer, infrared, ear
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Thermometer, infrared, ear
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218300
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218300

Vantage Medical Pty Ltd - Thermometer, infrared, ear

ARTG entry for

Medical Device Included Class IIa

Sponsor

Vantage Medical Pty Ltd

Postal Address

33 Allora Avenue,

FERNTREE GULLY, VIC, 3156

Australia

ARTG Start Date

9/12/2013

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

Radiant Innovation Inc

1F No 3 / Industrial E 9th Road Science-Based

Industrial Park

HsinChu, , 300

Taiwan (Province of China)

Products

1. Thermometer, infrared, ear

Product Type

Medical device system

Effective date

9/12/2013

GMDN

17887 Thermometer, infrared, ear

Intended purpose

to detect body temperature from the auditory canal using an infrared sensor and display the equivalent

oral temperature

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 10.11.2017 at 10:59:55 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

11-9-2018

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