Hepatic ultrasound elastography generator/analyser

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Medwheat Trade Aus Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
339618

Public Summary

Summary for ARTG Entry:

339618

Medwheat Trade Aus Pty Ltd - Hepatic ultrasound elastography generator/analyser

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medwheat Trade Aus Pty Ltd

Postal Address

8 Dudley Avenue, Wantirna, VIC, 3152

Australia

ARTG Start Date

16/07/2020

Product Category

Medical Device Class IIa

Status

Active

Approval Area

Medical Devices

Conditions

- 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

relevant information.

- 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.

Manufacturers

Name

Address

Wuxi Hisky Medical Technologies Co Ltd

Room B401 530 Plaza University Science Park

Taihu

International Science & Technology Park Wuxi,

Jiangsu Province, 214135

China

Products

1 . Hepatic ultrasound elastography generator/analyser

Product Type

Medical device system

Effective Date

16/07/2020

GMDN

58710 Hepatic ultrasound elastography generator/analyser

Intended Purpose

The system is indicated for the non-invasive measurement of liver stiffness and ultrasound attenuation parameter(UAP) in human

beings.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 22.07.2020 at 08:59:06 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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