Mask, surgical, single use

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

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Available from:
Medisa Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339897

Public Summary

Summary for ARTG Entry:

339897

Medisa Pty Ltd - Mask, surgical, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Medisa Pty Ltd

Postal Address

PO Box 3740, Marsfield, NSW, 2122

Australia

ARTG Start Date

21/07/2020

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

PHU DUC HUY PRODUCTION TRADING

SERVICES ONE MEMBER CO LTD

Hamlet 8 Luong Hoa Commune

Ben Luc District, Long An Province,

Vietnam

Products

1 . Mask, surgical, single use

Product Type

Single Device Product

Effective Date

21/07/2020

GMDN

35177 Mask, surgical, single use

Intended Purpose

A single-use face mask intended to protect both the patient and healthcare personnel from transmission of microorganisms/ body

fluid/ particulate material, and splash of blood.

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 08:04:27 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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