Main information

  • Trade name:
  • Mattress, bed,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Mattress, bed,
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222746
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Direct Healthcare Services Pty Ltd - Mattress, bed, <specify>

ARTG entry for

Medical Device Included Class 1


Direct Healthcare Services Pty Ltd

Postal Address

PO Box 562,WEMBLEY, WA, 6913


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Direct Healthcare Services Ltd

6-10 Withey Court

Western Industrial Estate, Caerphilly, CF83


1. Mattress, bed, <specify>

Product Type

Single Device Product

Effective date



12475 Mattress, bed, <specify>

Intended purpose

The Dyna-Form range of Pressure Redistribution Mattresses (Venus),(Saturn),(Jupiter)are designed for

both prevention and treatment of ulcers and are intended to be used in conjunction with an appropriately

sized bed frame, as part of an overall pressure ulcer prevention program of care.

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

Public Summary

Page 1 of

Produced at 09.11.2017 at 07:56:25 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.

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Garderie Dépôt recalls Dream on Me Portable Cribs

Garderie Dépôt recalls Dream on Me Portable Cribs

The distance between the top surface of the lowest fixed side and the top surface of the mattress support is lower than what is required by law, posing a fall hazard.

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