Meibomian gland expressor/evaluator, manual

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

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class 1
Authorization status:
Included
Authorization number:
292716

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Public Summary

Summary for ARTG Entry:

292716

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Meibomian gland expressor/evaluator, manual

ARTG entry for

Medical Device Included Class 1

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

12/08/2017

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

TearScience Inc

5151 McCrimmon Parkway Suite 250

Morrisville, NC, 27560

United States Of America

Products

1. Meibomian gland expressor/evaluator, manual

Product Type

Single Device Product

Effective date

12/08/2017

GMDN

62775 Meibomian gland expressor/evaluator, manual

Intended purpose

The device is intended for use by a physician to evaluate meibomian gland secretions.

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 01.12.2017 at 11:21:20 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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