Non-sterile scar management dressing, reusable

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Denward Dell Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
293075

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Public Summary

Summary for ARTG Entry:

293075

Denward Dell Pty Ltd - Non-sterile scar management dressing, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

Denward Dell Pty Ltd

Postal Address

15 Redland Drive,MITCHAM, VIC, 3132

Australia

ARTG Start Date

22/08/2017

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

Deutsch & Neumann GmbH

Richard Wagner Str 48-50

, Berlin, 10585

Germany

Products

1. Non-sterile scar management dressing, reusable

Product Type

Single Device Product

Effective date

22/08/2017

GMDN

44898 Non-sterile scar management dressing, reusable

Intended purpose

A non-sterile covering made of silicone-based material used in the management of scars

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 03.11.2017 at 05:56:32 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

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