Mask, surgical, single use

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

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Sẵn có từ:
Pakshir Medical Pty Ltd
Lớp học:
Class 1
Tình trạng ủy quyền:
Số ủy quyền:

Public Summary

Summary for ARTG Entry:


Pakshir Medical Pty Ltd - Mask, surgical, single use

ARTG entry for

Medical Device Included Class 1


Pakshir Medical Pty Ltd

Postal Address

U 2307 7 Riverside Quay, Southbank, VIC, 3006


ARTG Start Date


Product Category

Medical Device Class 1



Approval Area

Medical Devices


- 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.




Shanghai Jianzhong Medical Packaging

Company Limited

Building 16 No 789 Puxing Road Pujiang Town

Shanghai, ,



1 . Mask, surgical, single use

Product Type

Single Device Product

Effective Date



35177 Mask, surgical, single use

Intended Purpose

Disposable 3 Ply Face Mask with Earloop general purpose for protection against droplets, bodily fluids etc; Provides barrier

protection to prevent the transmission of airborne organisms.

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

Public Summary

Page 1 of

Produced at 22.07.2020 at 10:10:18 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.

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