Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medwheat Trade Aus Pty Ltd - Hepatic ultrasound elastography generator/analyser
ARTG entry for
Medical Device Included Class IIa
Medwheat Trade Aus Pty Ltd
8 Dudley Avenue, Wantirna, VIC, 3152
ARTG Start Date
Medical Device Class IIa
- 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.
Wuxi Hisky Medical Technologies Co Ltd
Room B401 530 Plaza University Science Park
International Science & Technology Park Wuxi,
Jiangsu Province, 214135
1 . Hepatic ultrasound elastography generator/analyser
Medical device system
58710 Hepatic ultrasound elastography generator/analyser
The system is indicated for the non-invasive measurement of liver stiffness and ultrasound attenuation parameter(UAP) in human
No Specific Conditions included on Record
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Produced at 22.07.2020 at 08:59:06 AEST
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