Nail treatment solution

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

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Available from:
LaCorium Health Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
324287

Public Summary

Summary for ARTG Entry:

324287

LaCorium Health Australia Pty Ltd - Nail treatment solution

ARTG entry for

Medical Device Included Class IIa

Sponsor

LaCorium Health Australia Pty Ltd

Postal Address

PO Box 1422,BONDI JUNCTION, NSW, 1355

Australia

ARTG Start Date

1/10/2019

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

Medical Brands Developments BV

Piet Heinkade 199

, Amsterdam, 1019 HC

Netherlands

Products

1. Nail treatment solution

Product Type

Single Device Product

Effective date

1/10/2019

GMDN

47918 Nail treatment solution

Intended purpose

to treat fungal infected nails by creating a barrier to, and an antagonistic environment for, microorganisms

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 03:12:56 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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