Nail

Main information

  • Trade name:
  • Nail treatment solution
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Nail treatment solution
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219480
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219480

Reckitt Benckiser Pty Ltd - Nail treatment solution

ARTG entry for

Medical Device Included Class 1

Sponsor

Reckitt Benckiser Pty Ltd

Postal Address

PO Box 20097 World Square,Sydney, NSW, 2002

Australia

ARTG Start Date

22/01/2014

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

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull, Yorkshire, HU8 7DS

Products

1. Nail treatment solution

Product Type

Single Device Product

Effective date

22/01/2014

GMDN

47918 Nail treatment solution

Intended purpose

It is intended for the self-treatment of mild fungal infections. The device is intended for use in two phases

including nail debridement where the top layers of the nail are physically removed with the nail file and

application of a liquid treatment for forming a film (barrier) over the nail, softening the nail and maintaining

an inhospitable environment where the fungus find it difficult to survive.

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 07:25:28 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