Mask, surgical, single use

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

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Available from:
Orien Dental Supplies
Class:
Class 1
Authorization status:
Included
Authorization number:
339835

Public Summary

Summary for ARTG Entry:

339835

Orien Dental Supplies - Mask, surgical, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Orien Dental Supplies

Postal Address

21 Castlewellan Boulevard, HILLSIDE, VIC, 3037

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

Shanghai Dochem Industries Co Ltd

Suite E2014 2nd Floor No 3558 Zhenbei Road

Putuo District, Shanghai, 200062

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

A disposable device made from fabric or other material placed over the nose and mouth by medical personnel to prevent the

transmission of airborne organisms while surgery is being performed.

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 08:17:43 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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