Soft

Main information

  • Trade name:
  • Soft corrective contact lens, daily-disposable
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Soft corrective contact lens, daily-disposable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221910
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221910

1001 Optical Pty Ltd - Soft corrective contact lens, daily-disposable

ARTG entry for

Medical Device Included Class IIa

Sponsor

1001 Optical Pty Ltd

Postal Address

Unit 30 / 6 Herbert Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

2/04/2014

Product category

Medical Device Class IIa

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

Interojo Inc

28 & 25 Sandan-ro 15beon-gil

Pyongtaek-city, Gyeonggi-do,

Korea - Republic of

Products

1. Soft corrective contact lens, daily-disposable

Product Type

Single Device Product

Effective date

2/04/2014

GMDN

47841 Soft corrective contact lens, daily-disposable

Intended purpose

Daily disposable contact lenses for vision correction

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 18.10.2017 at 04:59:24 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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