Web-based intraocular lens calculator

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)

01-11-2019

제공처:
Insight Surgical
수업:
Class 1
승인 상태:
Included
승인 번호:
322261

Public Summary

Summary for ARTG Entry:

322261

Insight Surgical - Web-based intraocular lens calculator

ARTG entry for

Medical Device Included Class 1

Sponsor

Insight Surgical

Postal Address

PO Box 7606,BAULKHAM HILLS DC, NSW, 2153

Australia

ARTG Start Date

26/08/2019

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

Medicontur Medical Engineering Ltd

1 Herceghalmi Road

, Zsambek, 2072

Hungary

Products

1. Web-based intraocular lens calculator

Product Type

Single Device Product

Effective date

26/08/2019

GMDN

52847 Web-based intraocular lens calculator

Intended purpose

Selection of optimal lens characteristics (including power) and lens placement in the eye

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 06:03:36 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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