Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Optimum Medical Australasia Pty Ltd - Surgical/medical respirator, single-use
ARTG entry for
Medical Device Included Class 1
Optimum Medical Australasia Pty Ltd
Level 4 470 Church Street, North Parramatta, NSW, 2151
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.
Hunan SanRui Biotechnology Co Ltd
2F Building C4 Gold Venture Park
Wangcheng Economic Development Zone,
1 . Surgical/medical respirator, single-use
Single Device Product
57794 Surgical/medical respirator, single-use
Optipro Particulate Respirator, a Filtering Face Piece 2 mask which has a non-woven protective layers which filter over 95% of
airborne particles including dust, bacteria, smoke, pollen and other pollutants.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 08:51:21 AEST
This is not an ARTG Certificate document.
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