Compress

Main information

  • Trade name:
  • Compress, hot/cold pack, reusable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Compress, hot/cold pack, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216535
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216535

Medigesia - Compress, hot/cold pack, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

Medigesia

Postal Address

1 / 48 Hewitt Street,Wilston, QLD, 4051

Australia

ARTG Start Date

24/10/2013

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 Yishun Ice Pack Co Ltd

No 6 Building No 1456 Xintanwa Road

Shanghai, , 201321

China

Products

1. Compress, hot/cold pack, reusable

Product Type

Single Device Product

Effective date

24/10/2013

GMDN

37240 Compress, hot/cold pack, reusable

Intended purpose

A device that is intended to be applied to the face and neck to provide cold or heat therapy to the

underlying tissue.

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 04:57:08 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