Wound

Main information

  • Trade name:
  • Wound hydrogel dressing, sterile
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Wound hydrogel dressing, sterile
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219975
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219975

Meditron Pty Ltd - Wound hydrogel dressing, sterile

ARTG entry for

Medical Device Included Class IIb

Sponsor

Meditron Pty Ltd

Postal Address

11 Dalmore Drive,Scoresby, VIC, 3179

Australia

ARTG Start Date

7/02/2014

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

KIKGEL

ul Sklodowskiej 7

, Ujazd, 97-225

Poland

Products

1. Wound hydrogel dressing, sterile

Product Type

Single Device Product

Effective date

7/02/2014

GMDN

47764 Wound hydrogel dressing, sterile

Intended purpose

The sterile hydrogel dressing is applied as a cooling and alleviative barrier to protect skin following laser

ablation, aesthetic medical procedures, plastic surgery and phlebology. It also supports the healing of

injured tissue. The dressing may be used during non-ablative laser procedures, as an elastic and

transparent contact layer which cools and protects the epidermis from thermal injures, thus improving the

quality of the procedure and the patient's level of comfort. The dressing is also is useful as a coupling

agent for ultrasound applications in cases of breached dermis or open wounds, or when a sterile and

transparent hydrogel cushion is necessary to improve visibility of surface structures.

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 05:49:28 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

There are no safety alerts related to this product.

2-10-2018

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