Exudate-absorbent dressing, hydrophilic-gel

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

Buy It Now

Available from:
Lavinia Medical Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
322590

Public Summary

Summary for ARTG Entry:

322590

Lavinia Medical Pty Ltd - Exudate-absorbent dressing, hydrophilic-gel

ARTG entry for

Medical Device Included Class IIb

Sponsor

Lavinia Medical Pty Ltd

Postal Address

No 63 Franklin Street,Forrest, ACT, 2603

Australia

ARTG Start Date

2/09/2019

Product category

Medical Device Class IIb

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

Hui Zhou Foryou Medical Devices Co Ltd

North Shangxia Road Dongjiang Hi-tech

Industry Park

, HuiZhou, 516005

China

Products

1. Exudate-absorbent dressing, hydrophilic-gel

Product Type

Single Device Product

Effective date

2/09/2019

GMDN

43186 Exudate-absorbent dressing, hydrophilic-gel

Intended purpose

Alginate dressing designed to be absorb wound exudates and form a gel-like covering cover the wound,

maintaining a moist wound healing environment which accelerated healing process and stops bleeding.

The gel-like surface also keeps the dressing from adhering to the wound.

Specific Conditions

© 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 02.11.2019 at 05:23:29 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

Search alerts related to this product

Share this information