Mask, surgical, single use

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

Buy It Now

Available from:
Rehab Assist Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339822

Public Summary

Summary for ARTG Entry:

339822

Rehab Assist Pty Ltd - Mask, surgical, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Rehab Assist Pty Ltd

Postal Address

PO Box 536, Bayswater, VIC, 3153

Australia

ARTG Start Date

20/07/2020

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

NINGBO WEIAIDA MEDICAL EQUIPMENT CO

NORTH SIDE OF CLASS I HIGHWAY

HUANGXI VILLAGE QIANGTOU TOWN

XIANGSHAN COUNTY

NINGBO CITY, ZHEJIANG PROVINCE,

China

Products

1 . Mask, surgical, single use

Product Type

Single Device Product

Effective Date

20/07/2020

GMDN

35177 Mask, surgical, single use

Intended Purpose

Intended Purpose A device intended to be placed over the nose and mouth of a health personnel to prevent the transmission of

airborne organisms during surgery or patient examination. This is a single-use device.

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 08:21:35 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

Search alerts related to this product

Share this information