Main information

  • Trade name:
  • Patch, eye
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Patch, eye
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217254
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Optimed Pty Ltd - Patch, eye

ARTG entry for

Medical Device Included Class 1


Optimed Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Lianyungang Tiannuo Optical Instrument Co

No 3 JinQiao Road Dapu Industrial Park

Lianyungang, Jiangsu, 222000



1. Patch, eye

Product Type

Single Device Product

Effective date



35715 Patch, eye

Intended purpose

To provide temporary occlusion for the eye in the treatment of Amblyopia, diplopia or as a occluder for

vision or field testing.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 02:45:36 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.

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