Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Solasta Life Pty Ltd - Public respirator, single-use
ARTG entry for
Medical Device Included Class 1
Solasta Life Pty Ltd
3 Disney Street, Stafford Heights, QLD, 4053
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.
Guangdong Fei Fan Mstar Technology Ltd
A1 workshop No 10 Dongnan Xincun Avenue
Zone 2 Caobian No 3 Industrial Zone
Dali Town Foshan City, Nanhai District,
1 . Public respirator, single-use
Single Device Product
57793 Public respirator, single-use
A filtering mask KN95 (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
emergency (e.g., influenza pandemic). It is typically made of multiple layers of non-woven polymers, and incorporates a forming
(metal wire); it is typically secured using elastic head straps. This is a single-use device.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 08:07:17 AEST
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