Sealing unit, packaging

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

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Available from:
Mediquip Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
321380

Public Summary

Summary for ARTG Entry:

321380

Mediquip Pty Ltd - Sealing unit, packaging

ARTG entry for

Medical Device Included Class 1

Sponsor

Mediquip Pty Ltd

Postal Address

PO Box 4097,LOGANHOLME, QLD, 4129

Australia

ARTG Start Date

7/08/2019

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

Famos BV

Noorderpoort 20

Venlo, PJ, 5916

Netherlands

Products

1. Sealing unit, packaging

Product Type

Single Device Product

Effective date

7/08/2019

GMDN

36674 Sealing unit, packaging

Intended purpose

A device used for sealing packaged products and utensils, e.g. sterilized intruments/equipment. It is

typically used in operation theatre units, sterile packaging centres, and laboratories. The product uses heat

to create an airtight seal

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 07:47:23 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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