Alternating-pressure bed mattress overlay system

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

Buy It Now

Available from:
Juvo Solutions Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339573

Public Summary

Summary for ARTG Entry:

339573

Juvo Solutions Pty Ltd - Alternating-pressure bed mattress overlay system

ARTG entry for

Medical Device Included Class 1

Sponsor

Juvo Solutions Pty Ltd

Postal Address

PO Box 261, Bentley, WA, 6982

Australia

ARTG Start Date

15/07/2020

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

Care of Sweden AB

Fabriksgatan 5A

, Tranemo, 514 33

Sweden

Products

1 . Alternating-pressure bed mattress overlay system

Product Type

Single Device Product

Effective Date

15/07/2020

GMDN

47478 Alternating-pressure bed mattress overlay system

Intended Purpose

A device to be used on top of a bed making the surface more comfortable by relieving pressure points and preventing bed sores.

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 22.07.2020 at 09:07:13 AEST

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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