Nail

Main information

  • Trade name:
  • Nail treatment solution
  • Class:
  • Class IIa
  • 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:
  • 221559
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221559

Arrow Pharma Pty Ltd - Nail treatment solution

ARTG entry for

Medical Device Included Class IIa

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

21/03/2014

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

Moberg Derma AB

Gunnar Asplunds Alle 32 Hus D

Solna, , SE-171 63

Sweden

Products

1. Nail treatment solution

Product Type

Single Device Product

Effective date

21/03/2014

GMDN

47918 Nail treatment solution

Intended purpose

A non-sterile topical solution in a plastic applicator with a silicone drop tip for application to nails. It

promotes healing of discoloured & deformed nails (onychodystrophy) due to onychomycosis or psoriasis. It

hydrates & smooths the outer layers of the nail plate & changes the nail's microenvironment (low pH,

altered osmotic environment) to create an antagonistic environment for microorganisms & improves nail

surface integrity, creating a barrier which prevents growth of fungi & bacteria

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 12:41:01 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