Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Intex International Group Pty Ltd - Mask, surgical, single use
ARTG entry for
Medical Device Included Class 1
Intex International Group Pty Ltd
10/2 Slough Avenue Slough Business Park, Silverwater, NSW, 2128
ARTG Start Date
Medical Device Class 1
- 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
- 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.
Henan Tuoren Medical Device Co., Ltd.
Weiyuan Industrial Zone Menggang Changyuan
, Henan, 453400
1 . Mask, surgical, single use
Single Device Product
35177 Mask, surgical, single use
Intended to provide protection for the user from various air borne substances including droplets. The mask also protects people
around the user from exhaled droplets etc. This mask is intended for use in clinical and isolation environments.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 09:24:30 AEST
This is not an ARTG Certificate document.
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