Pneumatic/ultrasonic lithotripsy system probe

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

Buy It Now

Available from:
MD Solutions Australasia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322624

Public Summary

Summary for ARTG Entry:

322624

MD Solutions Australasia Pty Ltd - Pneumatic/ultrasonic lithotripsy system probe

ARTG entry for

Medical Device Included Class IIa

Sponsor

MD Solutions Australasia Pty Ltd

Postal Address

Unit 1/16-18 Tennyson Street,WILLIAMSTOWN NORTH, VIC, 3016

Australia

ARTG Start Date

3/09/2019

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

EMS Electro Medical Systems SA

Chemin De La Vuarpilliere 31

NYON, 1260,

Switzerland

Products

1. Pneumatic/ultrasonic lithotripsy system probe

Product Type

Single Device Product

Effective date

3/09/2019

GMDN

64380 Pneumatic/ultrasonic lithotripsy system probe

Intended purpose

Probe intended to be used in conjunction with the lithotriptor to send ultrasound and pressure waves,

either together or alternatively, to stones in the urinary tract (kidney, ureter and bladder), breaking stones

down and removing them through its lumen by suction. This is a sterile, single-use device.

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 05:18:24 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

Search alerts related to this product

Share this information