Compression system stocking/suit/sleeve, multi-chamber, single-use

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

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Available from:
Oped Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
290566

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Public Summary

Summary for ARTG Entry:

290566

Oped Australia Pty Ltd - Compression system stocking/suit/sleeve, multi-chamber, single-use

ARTG entry for

Medical Device Included Class 1

Sponsor

Oped Australia Pty Ltd

Postal Address

2/97 Montague Street,WOLLONGONG, NSW, 2500

Australia

ARTG Start Date

22/06/2017

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

Oped GmbH

Medizinpark 1 Valley

, Oberlaindern, 83626

Germany

Products

1. Compression system stocking/suit/sleeve, multi-chamber, single-use

Product Type

Single Device Product

Effective date

22/06/2017

GMDN

44762 Compression system stocking/suit/sleeve, multi-chamber, single-use

Intended purpose

Foot/Ankle and Calf compression garment used in conjunction with compression pump. Mainly used for

prevention of DVT.

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 03:32:30 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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