Multi-purpose

Main information

  • Trade name:
  • Multi-purpose digital medical camera external ophthalmoscopic lens
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Multi-purpose digital medical camera external ophthalmoscopic lens
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221799
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221799

Heidelberg Engineering Pty Ltd - Multi-purpose digital medical camera external ophthalmoscopic lens

ARTG entry for

Medical Device Included Class IIa

Sponsor

Heidelberg Engineering Pty Ltd

Postal Address

404 Albert Street,EAST MELBOURNE, VIC, 3002

Australia

ARTG Start Date

28/03/2014

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

Heidelberg Engineering GmbH

Max-Jarecki-Strasse 8

, Heidelberg, 69115

Germany

Products

1. Multi-purpose digital medical camera external ophthalmoscopic lens

Product Type

Single Device Product

Effective date

28/03/2014

GMDN

58860 Multi-purpose digital medical camera external ophthalmoscopic lens

Intended purpose

The Ultra Widefield Angiography module is an objective lens to acquire a 102' image of the retina. This is

an accessory to the Spectralis.

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 09.11.2017 at 11:47:24 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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