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:
  • 217905
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217905

Medical Industries Australia - Adhesive strip, skin-closure

ARTG entry for

Medical Device Included Class Is

Sponsor

Medical Industries Australia

Postal Address

512 Creek Street,ALBURY, NSW, 2640

Australia

ARTG Start Date

29/11/2013

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

Danyang Sunmed Healthcare Co

No 3 Bei Er Huan Danyang City

, Jiangsu Province, 212300

China

Products

1. Adhesive strip, skin-closure

Product Type

Single Device Product

Effective date

29/11/2013

GMDN

32207 Adhesive strip, skin-closure

Intended purpose

This is a sterile small narrow flexible band that is an adhesive strip that is intended to be used to cover

superficial wound or fix a dressing to 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 10.11.2017 at 12:34:38 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