Adhesive

Main information

  • Trade name:
  • Adhesive strip,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Adhesive strip,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221315
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221315

Bayer Australia Ltd - Adhesive strip, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

15/03/2014

Product category

Medical Device Class 1

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

Lohmann & Rauscher International GmbH & Co

Westerwaldstrasse 4

, Rengsdorf, 56579

Germany

Products

1. Adhesive strip, <specify>

Product Type

Single Device Product

Effective date

15/03/2014

GMDN

10026 Adhesive strip, <specify>

Intended purpose

A flexible strip (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive

adhesive, typically used to cover or approximate the edges of superficial wounds or fix dressings to skin.

The device may include an adhesive pad and have qualities such as waterproof. The device is usually

supplied in precut sizes/shapes. 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 01:27:14 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