Main information

  • Trade name:
  • Trocar, abdominal
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Trocar, abdominal
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219768
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Koala Medical Pty Ltd - Trocar, abdominal

ARTG entry for

Medical Device Included Class IIa


Koala Medical Pty Ltd

Postal Address

PO Box 1191,MONA VALE, NSW, 2103


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.




Unimax Medical Systems Inc

8F-2 No 127 Lane 235 Pao Chiao Road

Hsin Tien City, Taipei,

Taiwan (Province of China)


1. Trocar, abdominal

Product Type

Single Device Product

Effective date



14155 Trocar, abdominal

Intended purpose

A surgical instrument which is supplied sterile and features a sharp pyramidal or conical point used to

puncture the abdomen wall. It can be assembled and used together with a compatible sleeve filling its

lumen thereby allowing the introduction of this assembly. Following puncture, the Trocar is withdrawn

providing a working channel to the cavity.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 06:38:22 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.

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