Gel, ultrasonic coupling

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

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Available from:
Lavinia Medical Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
321384

Public Summary

Summary for ARTG Entry:

321384

Lavinia Medical Pty Ltd - Gel, ultrasonic coupling

ARTG entry for

Medical Device Included Class 1

Sponsor

Lavinia Medical Pty Ltd

Postal Address

No 63 Franklin Street,Forrest, ACT, 2603

Australia

ARTG Start Date

7/08/2019

Product category

Medical Device Class 1

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

Anji Sunlight Medical Products Co Ltd

Sunlight Industry Zone

Anji County, Zhejiang Prov., 0

China

Products

1. Gel, ultrasonic coupling

Product Type

Single Device Product

Effective date

7/08/2019

GMDN

15321 Gel, ultrasonic coupling

Intended purpose

Gel used between the patient skin and ultrasound transducer for better contact during an ultrasound

examination.

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 02.11.2019 at 07:45:57 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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