General ultrasound imaging system, battery-powered

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

Buy It Now

Available from:
Hoyland Medical Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
323740

Public Summary

Summary for ARTG Entry:

323740

Hoyland Medical Pty Ltd - General ultrasound imaging system, battery-powered

ARTG entry for

Medical Device Included Class IIa

Sponsor

Hoyland Medical Pty Ltd

Postal Address

Unit 7 / 22 Palmer Place,MURARRIE, QLD, 4172

Australia

ARTG Start Date

18/09/2019

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

Hunan Ramzed Medical Imaging Technology

Co Ltd

No.380 Baling East Road Yueyang City

, Hunan Province, 414000

China

Products

1. General ultrasound imaging system, battery-powered

Product Type

Single Device Product

Effective date

18/09/2019

GMDN

60924 General ultrasound imaging system, battery-powered

Intended purpose

Hand Held wireless ultrasound device. used for images of internal anatomy, such as Bladder retention,

vascular, Gynaecology and bone and soft tissue injury.

Specific Conditions

© 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 08.11.2019 at 10:26:51 AEDT

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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