Thermometer

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221780
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221780

Silverline Medical Pty Ltd - Thermometer, infrared, skin

ARTG entry for

Medical Device Included Class IIa

Sponsor

Silverline Medical Pty Ltd

Postal Address

PO Box 8171,Tumbi Umbi, NSW, 2154

Australia

ARTG Start Date

28/03/2014

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

Rossmax International Ltd

12F No 189 Kang Chien Road

, Taipei 114,

Taiwan (Province of China)

Products

1. Thermometer, infrared, skin

Product Type

Single Device Product

Effective date

28/03/2014

GMDN

17888 Thermometer, infrared, skin

Intended purpose

This is a measuring device that is intended to be used for determining the patient's body temperature. It is

used to estimate the temperature of a site on the skin.

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 09.11.2017 at 11:51:36 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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