Endotherapy needle, single use

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

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Available from:
Endo X
Class:
Class IIa
Authorization status:
Included
Authorization number:
324205

Public Summary

Summary for ARTG Entry:

324205

Endo X - Endotherapy needle, single use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Endo X

Postal Address

141 Cranbourne Road,Frankstoin, VIC, 3199

Australia

ARTG Start Date

30/09/2019

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

Jiangsu Vedkang Medical Science &

Technology Co Ltd

No 52 Guoxiang Road Wujin Economic

Develeopment Zone

Changzhou, Jiangsu, 213164

China

Products

1. Endotherapy needle, single use

Product Type

Single Device Product

Effective date

30/09/2019

GMDN

38825 Endotherapy needle, single use

Intended purpose

Injection needle to introduce an agent endoscopically through a body orifice into selective sites to control

actual or potential bleeding lesions in the digestive system and for endoscopic mucosal resection.

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 03:27:15 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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