Sterilizer, moist heat, wrapped goods

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

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Available from:
Utech Medical Device Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
339210

Public Summary

Summary for ARTG Entry:

339210

Utech Medical Device Pty Ltd - Sterilizer, moist heat, wrapped goods

ARTG entry for

Medical Device Included Class IIb

Sponsor

Utech Medical Device Pty Ltd

Postal Address

20 Chapel Street, Magill, SA, 5072

Australia

ARTG Start Date

8/07/2020

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

Ningbo Wanrui Medical Instrument Co Ltd

Chen Heng Lou Village Gulin Town

Ningbo, Zhejiang, 315176

China

Products

1 . Sterilizer, moist heat, wrapped goods

Product Type

Single Device Product

Effective Date

8/07/2020

GMDN

38671 Sterilizer, moist heat, wrapped goods

Intended Purpose

Intended for the sterilization of all wrapped or non-wrapped, solid, hollow products type B and porous products as well as surgical

instruments.

This sterilizer is used in dental clinic, laboratory, operation room, emergency room, ophthalmology, gynaecology and steam,

cosmetic hospital and so on. It is used especially by doctors and professionals.

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 22.07.2020 at 10:16:18 AEST

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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