Wound hydrogel dressing, sterile

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

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Available from:
GP Medical Supplies Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
294172

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Public Summary

Summary for ARTG Entry:

294172

GP Medical Supplies Australia Pty Ltd - Wound hydrogel dressing, sterile

ARTG entry for

Medical Device Included Class IIa

Sponsor

GP Medical Supplies Australia Pty Ltd

Postal Address

PO Box 780,Artarmon, NSW, 2064

Australia

ARTG Start Date

20/09/2017

Product category

Medical Device Class IIa

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

Roosin Medical Co Ltd

No 8 Yuandong Road Kouan Town Gaogang

Taizhou City

Jiangsu Province, , 225321

China

Products

1. Wound hydrogel dressing, sterile

Product Type

Single Device Product

Effective date

20/09/2017

GMDN

47764 Wound hydrogel dressing, sterile

Intended purpose

The intended purpose of the gel wound dressing is to promote wound healing by maintaining a moist

wound environment..

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 02:22:57 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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