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:
  • 222467
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222467

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

14/04/2014

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

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

14/04/2014

GMDN

58860 Multi-purpose digital medical camera external ophthalmoscopic lens

Intended purpose

Anterior Segment Module is an accessory

to the SPECTRALIS and

is indicated for imaging the anterior segment of the eye, including

sclera, cornea, anterior chamber angles, and iris, and to perform

measurements of the anterior anatomic structures with necessary software.

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 09:29:56 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

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

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Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

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Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

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Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

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Notice of call for expressions of interest - Multiplex serologie

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1-10-2018

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28-9-2018

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21-9-2018

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Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

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Health Canada

14-9-2018

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10-9-2018

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FDA - U.S. Food and Drug Administration

1-9-2018

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29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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17-8-2018

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14-8-2018

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9-8-2018

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2-8-2018

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Europe - EMA - European Medicines Agency

26-7-2018

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Europe - EFSA - European Food Safety Authority Press Releases & News Stories

18-7-2018

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FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Thalidomide,  for the: Treatment of multiple myeloma

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Europe - EMA - European Medicines Agency

14-7-2018

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FDA - U.S. Food and Drug Administration

26-6-2018

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16-6-2018

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FDA - U.S. Food and Drug Administration

16-6-2018

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FDA - U.S. Food and Drug Administration

15-6-2018

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15-6-2018

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FDA - U.S. Food and Drug Administration

9-6-2018

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FDA - U.S. Food and Drug Administration

29-5-2018

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Europe - EMA - European Medicines Agency

29-5-2018

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Europe - EMA - European Medicines Agency

19-5-2018

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11-5-2018

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10-5-2018

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FDA - U.S. Food and Drug Administration

9-5-2018

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2-5-2018

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19-4-2018

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16-3-2018

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22-1-2018

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FDA - U.S. Food and Drug Administration

5-10-2017

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Danish Medicines Agency

9-7-2013

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Danish Medicines Agency

27-6-2011

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25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

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FDA - U.S. Food and Drug Administration

22-8-2018

BTVPUR (Merial)

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Europe -DG Health and Food Safety

6-8-2018

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Europe - EMA - European Medicines Agency

19-7-2018

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Europe - EMA - European Medicines Agency

3-7-2018

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices  https://

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FDA - U.S. Food and Drug Administration

25-5-2018

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Therapeutic Goods Administration - Australia