Shield, face

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

Buy It Now

Available from:
MLM Corp Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339720

Public Summary

Summary for ARTG Entry:

339720

MLM Corp Pty Ltd - Shield, face

ARTG entry for

Medical Device Included Class 1

Sponsor

MLM Corp Pty Ltd

Postal Address

Suite 100 8/6 Endeavour Blvd, North Lakes, QLD, 4509

Australia

ARTG Start Date

17/07/2020

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

Shandong INTCO Medical Products Co Ltd

Qiwang Road Nao Shan Industrial Park

Qingzhou, Shandong, 262500

China

Products

1 . Shield, face

Product Type

Single Device Product

Effective Date

17/07/2020

GMDN

11961 Shield, face

Intended Purpose

Disposable face shield with foam top and elastic band is a new protective product integrating eye, mouth and nose protection. It is

widely used in hospitals, dentistry, and other health research institutions, medicine, food, cosmetics and other industries.

· Lightweight, anti-fog protection from splashing or spraying

· Optically clear polyester for maximum visibility

· Can be worn with or without glasses

· Qualified with CE certificate

· Non-sterile

· Not Made with Natural Rubber Latex

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 08:36:48 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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