Spectacle

Main information

  • Trade name:
  • Spectacle lens occluder
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Spectacle lens occluder
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217253
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217253

Optimed Pty Ltd - Spectacle lens occluder

ARTG entry for

Medical Device Included Class 1

Sponsor

Optimed Pty Ltd

Postal Address

Unit 1a 7-9 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

13/11/2013

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

Lianyungang Tiannuo Optical Instrument Co

No 3 JinQiao Road Dapu Industrial Park

Lianyungang, Jiangsu, 222000

China

Products

1. Spectacle lens occluder

Product Type

Single Device Product

Effective date

13/11/2013

GMDN

46490 Spectacle lens occluder

Intended purpose

A hand held or frame placed device,usually constructed from plastic. It is used to occlude a person's eye

for the purpose of testing vision or assessing ocular movements.

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 02:45:51 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