Bandage

Main information

  • Trade name:
  • Bandage, pressure
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bandage, pressure
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216293
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216293

Livingstone International Pty Ltd - Bandage, pressure

ARTG entry for

Medical Device Included Class Is

Sponsor

Livingstone International Pty Ltd

Postal Address

106-116 Epsom Road,ROSEBERY, NSW, 2018

Australia

ARTG Start Date

21/10/2013

Product category

Medical Device Class Is

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

Suzhou Industrial Park Vicon Hygienic Material

Co Ltd

No 18 Zhihe Dong Road Weiting Western

District Suzhou Industrial Park

Suzhou, Jiangsu, 215122

China

Products

1. Bandage, pressure

Product Type

Single Device Product

Effective date

21/10/2013

GMDN

10284 Bandage, pressure

Intended purpose

"A device used to stop bleeding, prevent oedema or provide support designed in piece, strip, or roll of

fabric or plastic material"

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 05:22:31 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