Irrigation/aspiration system tubing set

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

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Available from:
Multigate Medical Products Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
324260

Public Summary

Summary for ARTG Entry:

324260

Multigate Medical Products Pty Ltd - Irrigation/aspiration system tubing set

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Multigate Medical Products Pty Ltd

Postal Address

27 Llewellyn Avenue,VILLAWOOD, NSW, 2163

Australia

ARTG Start Date

1/10/2019

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

Multigate Co Ltd

No 7 Lanjiang Road

Shaoxing, , 312000

China

Products

1. Irrigation/aspiration system tubing set

Product Type

Single Device Product

Effective date

1/10/2019

GMDN

47625 Irrigation/aspiration system tubing set

Intended purpose

A collection of sterile, flexible, double-bore tubing, and associated items intended as an

irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide

aspiration through the other during a surgical procedure.

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 03:15:32 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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