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Public Summary

Summary for ARTG Entry:

333084

TV Media Australia Pty Ltd - Mask, surgical, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

TV Media Australia Pty Ltd

Postal Address

PO Box 20577, World Square, NSW, 2002 Australia

ARTG Start Date

1/04/2020

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.

Address 4/F Building A CLP Industrial Park Longling Industrial Park Yuancheng District Heyuan City, Guangdong, China

Products

1. Mask, surgical, single use Product Type

Single Device Product

Effective date

1/04/2020

GMDN

35177 Mask, surgical, single use

Intended purpose

A single use device made from non woven fabrics which is placed over the nose and mouth by medical personnel to prevent the transmission of air borne organisms

Specific Conditions

Š 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.

Page 1 of 1 Produced at 14.04.2020 at 06:54:39 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

Public Summary

Manufacturers Name Guangdong Kanghua Medical Technology Co Ltd


Public Summary

Summary for ARTG Entry:

333600

TV Media Australia Pty Ltd - Public N95 respirator

ARTG entry for

Medical Device Included Class 1

Sponsor

TV Media Australia Pty Ltd

Postal Address

PO Box 20577, World Square, NSW, 2002 Australia

ARTG Start Date

7/04/2020

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 CTT Co Ltd

Products

1. Public N95 respirator Product Type

Effective date

Single Device Product

7/04/2020

GMDN

57793 Public N95 respirator

Intended purpose

A filtering mask [N95 (filter efficiency 95%)] designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency (e.g., influenza pandemic). This is a single-use device.

Specific Conditions

Š 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.

Page 1 of 1 Produced at 14.04.2020 at 01:24:07 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

Public Summary

Address Building 2 No197 Plant East Side of XinHua Road Tongqiao Town ZhongKai High-Tech Zone HuiZhou City, Guangdong Province, China


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