Surgical/medical respirator, single-use

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

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Available from:
Optimum Medical Australasia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339656

Public Summary

Summary for ARTG Entry:

339656

Optimum Medical Australasia Pty Ltd - Surgical/medical respirator, single-use

ARTG entry for

Medical Device Included Class 1

Sponsor

Optimum Medical Australasia Pty Ltd

Postal Address

Level 4 470 Church Street, North Parramatta, NSW, 2151

Australia

ARTG Start Date

16/07/2020

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

Hunan SanRui Biotechnology Co Ltd

2F Building C4 Gold Venture Park

Wangcheng Economic Development Zone,

Hunan,

China

Products

1 . Surgical/medical respirator, single-use

Product Type

Single Device Product

Effective Date

16/07/2020

GMDN

57794 Surgical/medical respirator, single-use

Intended Purpose

Optipro Particulate Respirator, a Filtering Face Piece 2 mask which has a non-woven protective layers which filter over 95% of

airborne particles including dust, bacteria, smoke, pollen and other pollutants.

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 08:51:21 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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