Main information

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



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

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221258
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


AJ Harry - Thermometer, infrared, ear

ARTG entry for

Medical Device Included Class IIa


AJ Harry

Postal Address

PO Box 1291,NAIRNE, SA, 5252


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Famidoc Technology Co Ltd

No 212 Yilong Road Hexi Industrial Zone

Jinxia Changan Town Dongguan, Guangdong

Province, 523853



1. Thermometer, infrared, ear

Product Type

Single Device Product

Effective date



17887 Thermometer, infrared, ear

Intended purpose

This device is a high technology medical thermometer for measuring the eardrum and forehead

temperature of the human body via infrared rays emitted from the eardrum and skin surface, which allows

the user to identify the temperature easily and quickly. Can be used for new-borns, children and adults.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 01:36:47 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.

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