Sizer,

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

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Available from:
Device Technologies Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
323100

Public Summary

Summary for ARTG Entry:

323100

Device Technologies Australia Pty Ltd - Sizer, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

12/09/2019

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

AJL Ophthalmic SA

Ferdinand Zeppelin 1 Parque Tecnologico de

Alava

, Minano Alava, 01510

Spain

Products

1. Sizer, <specify>

Product Type

Procedure Pack

Effective date

12/09/2019

GMDN

18086 Sizer, <specify>

Intended purpose

A collection of reusable oculoplasty instruments intended to estimate the size of the patient's eye during

surgery.

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 04:24:34 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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