Spring-loaded pneumoperitoneum needle, single-use

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

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Optimed Technologies Pty Ltd
Class IIa
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Medical & Optical Instruments Australia Pty Ltd - Spring-loaded pneumoperitoneum needle, single-use

ARTG entry for

Medical Device Included Class IIa


Medical & Optical Instruments Australia Pty Ltd

Postal Address

PO Box 850,ARTARMON, NSW, 1570


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Hangzhou Optcla Medical Instruments Co Ltd

No.2 Fengxiang Road Economic Development

Zone Tonglu Hangzhou

, Zhejiang, 311508



1. Spring-loaded pneumoperitoneum needle, single-use

Product Type

Single Device Product

Effective date



12750 Spring-loaded pneumoperitoneum needle, single-use

Intended purpose

Spring loaded pneumoperitoneum needle single use item.

A slender metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or

surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of

insulflation to establish pneumoperitoneum prior to abdominal endoscopy.

Specific Conditions

No Specific Conditions included on Record

© 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

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Produced at 03.11.2017 at 04:13:39 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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