Sheet

Main information

  • Trade name:
  • Sheet, examination/treatment table, single use
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sheet, examination/treatment table, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219199
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219199

Shantex Pty Ltd - Sheet, examination/treatment table, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Shantex Pty Ltd

Postal Address

PO Box 979,ARCHERFIELD, QLD, 4108

Australia

ARTG Start Date

14/01/2014

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

Shanghai Yuanchang Compound Material Ltd

No 698 Wangan Road Waigang Town Jiading

District

Shanghai, ,

China

Products

1. Sheet, examination/treatment table, single use

Product Type

Single Device Product

Effective date

14/01/2014

GMDN

35557 Sheet, examination/treatment table, single use

Intended purpose

This single use sheet (approx. 40x55cm) is typically made of 4 ply absorbent tissue material with a water

resistant blue plastic type backing. This sheet is used to protect furniture and equipment from medical and

body fluid leakage in healthcare facilities.

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 10.11.2017 at 08:15:30 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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