Rigid-gas-permeable corrective contact lens, daily-wear

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

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Available from:
Capricornia Contact Lens Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
324148

Public Summary

Summary for ARTG Entry:

324148

Capricornia Contact Lens Pty Ltd - Rigid-gas-permeable corrective contact lens, daily-wear

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Capricornia Contact Lens Pty Ltd

Postal Address

2 / 9 Cronulla Court,SLACKS CREEK, QLD, 4127

Australia

ARTG Start Date

27/09/2019

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

Capricornia Contact Lens Pty Ltd

2 / 9 Cronulla Court

SLACKS CREEK, QLD, 4127

Australia

Products

1. Rigid-gas-permeable corrective contact lens, daily-wear

Product Type

Single Device Product

Effective date

27/09/2019

GMDN

47840 Rigid-gas-permeable corrective contact lens, daily-wear

Intended purpose

Intended for visual correction of myopia, hyperopia, asigmatism, presbyopia, and/or treatment of

keratoconus, ocular surface disease, irregular cornea, post surgery or dry 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 03:36:47 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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