Ear nose throat

Main information

  • Trade name:
  • Ear/nose/throat treatment unit
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ear/nose/throat treatment unit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217769
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217769

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd - Ear/nose/throat treatment unit

ARTG entry for

Medical Device Included Class 1

Sponsor

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Postal Address

Locked Bag 3,

Ermington, NSW, 2115

Australia

ARTG Start Date

27/11/2013

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

Laboratoire De La Mer

ZAC La Madelaine Avenue de General Patton

Saint-Malo, , 35400

France

Products

1. Ear/nose/throat treatment unit

Product Type

Single Device Product

Effective date

27/11/2013

GMDN

11585 Ear/nose/throat treatment unit

Intended purpose

Nasal irrigation saline solution, non-sterile

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 01:05:05 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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