Adhesive

Main information

  • Trade name:
  • Adhesive strip, skin-closure
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Adhesive strip, skin-closure
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216647
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216647

Livingstone International Pty Ltd - Adhesive strip, skin-closure

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

28/10/2013

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

Firstar Healthcare Co Ltd

Rm 1003 East Tower Huapu Office Complex 13

Huaming Road

Zhujiang New City, Guangzhou, 510620

China

Products

1. Adhesive strip, skin-closure

Product Type

Single Device Product

Effective date

28/10/2013

GMDN

32207 Adhesive strip, skin-closure

Intended purpose

A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a

pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be

hypoallergenic and/or waterproof. This is a single-use device

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 04:37:54 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