Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Pro-Tek Plastics Australia - Mask, surgical, single use
ARTG entry for
Medical Device Included Class 1
Pro-Tek Plastics Australia
PO Box 531, ELTHAM, VIC, 3095
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.
Crown Name (WH) United Co Ltd
Changhang Building RM 1805 No 69 Yanjiang
Wuhan, Hubei, 430021
1 . Mask, surgical, single use
Single Device Product
35177 Mask, surgical, single use
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 while surgery is being performed.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 07:59:43 AEST
This is not an ARTG Certificate document.
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