Aquaboss - Reverse-osmosis water purification system

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

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Available from:
B Braun Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
321564

Public Summary

Summary for ARTG Entry:

321564

B Braun Australia Pty Ltd - Aquaboss - Reverse-osmosis water purification system

ARTG entry for

Medical Device Included Class IIb

Sponsor

B Braun Australia Pty Ltd

Postal Address

PO Box 6221,BAULKHAM HILLS DC, NSW, 2153

Australia

ARTG Start Date

9/08/2019

Product category

Medical Device Class IIb

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

Lauer Membran Wassertechnik GmbH

Industriegebiet Speichenatt WITTLINGEN

, WITTLINGEN, D-79599

Germany

Products

1. Aquaboss - Reverse-osmosis water purification system

Product Type

Medical device system

Effective date

9/08/2019

GMDN

14437 Reverse-osmosis water purification system

Intended purpose

Reverse osmosis system for the production of dialysis water

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 07:22:55 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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