Nebulizer

Main information

  • Trade name:
  • Nebulizer, non-heated
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Nebulizer, non-heated
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218363
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218363

Livingstone International Pty Ltd - Nebulizer, non-heated

ARTG entry for

Medical Device Included Class IIa

Sponsor

Livingstone International Pty Ltd

Postal Address

106-116 Epsom Road,ROSEBERY, NSW, 2018

Australia

ARTG Start Date

11/12/2013

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

Shenzhen Aeon Technology Co Ltd

East 5/F Block 15 Industrial Zone of Majialong

Nanshan District, Shenzhen, 518052

China

Products

1. Nebulizer, non-heated

Product Type

Medical device system

Effective date

11/12/2013

GMDN

35457 Nebulizer, non-heated

Intended purpose

A device that provides aerosolized humidification or medication for a patient to inspire. The device may

include an oxygen or air source to provide generation of the aerosol, a reservoir for the medication, a

baffle, and a compressor.

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 10:44:43 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