Sterilizer

Main information

  • Trade name:
  • Sterilizer, moist heat, wrapped goods
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sterilizer, moist heat, wrapped goods
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219977
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219977

Gallay Medical and Scientific Pty Ltd - Sterilizer, moist heat, wrapped goods

ARTG entry for

Medical Device Included Class IIb

Sponsor

Gallay Medical and Scientific Pty Ltd

Postal Address

PO Box 2394,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

7/02/2014

Product category

Medical Device Class IIb

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

Euronda SPA

Via Dell Artigianto 7

Montecchio Precalcino, Vicenza,

Italy

Products

1. Sterilizer, moist heat, wrapped goods

Product Type

Single Device Product

Effective date

7/02/2014

GMDN

38671 Sterilizer, moist heat, wrapped goods

Intended purpose

Sterilizer intended to be used to sterilize packaged medical devices. These medical devices can be such

items as surgical instruments, dental hand pieces, dental surgical instruments and other devices used

within a surgical environment and require sterilization prior to use.

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 05:48:58 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