Multi-purpose digital medical camera external ophthalmoscopic lens

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

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Available from:
Device Technologies Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
321810

Public Summary

Summary for ARTG Entry:

321810

Device Technologies Australia Pty Ltd - Multi-purpose digital medical camera external ophthalmoscopic

lens

ARTG entry for

Medical Device Included Class 1

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

15/08/2019

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

Marco Ophthalmic

11825 Central Parkway

JACKSONVILLE, FLORIDA, 32224

United States Of America

Products

1. Multi-purpose digital medical camera external ophthalmoscopic lens

Product Type

Single Device Product

Effective date

15/08/2019

GMDN

58860 Multi-purpose digital medical camera external ophthalmoscopic lens

Intended purpose

An optical device, which couples a portion of the light from a multi-purpose digital medical camera to a

user-provided smartphone for documentation purposes.

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 06:52:36 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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