Sealing unit, packaging

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

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Available from:
Getz Healthcare Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
292570

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Public Summary

Summary for ARTG Entry:

292570

Getz Healthcare Pty Ltd - Sealing unit, packaging

ARTG entry for

Medical Device Included Class 1

Sponsor

Getz Healthcare Pty Ltd

Postal Address

5 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

8/08/2017

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

Moller Medical GmbH

Wasserkuppenstrasse 29-31

Fulda, , 36043

Germany

Products

1. Sealing unit, packaging

Product Type

Single Device Product

Effective date

8/08/2017

GMDN

36674 Sealing unit, packaging

Intended purpose

An automated sealing unit designed to be used for sealing of tubing during blood donation or when

processing and storing blood bags.

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 03.11.2017 at 08:24:11 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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