Sigmoidoscope

Main information

  • Trade name:
  • Sigmoidoscope, rigid
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sigmoidoscope, rigid
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216526
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216526

Koala Medical Pty Ltd - Sigmoidoscope, rigid

ARTG entry for

Medical Device Included Class IIa

Sponsor

Koala Medical Pty Ltd

Postal Address

PO Box 1191,MONA VALE, NSW, 2103

Australia

ARTG Start Date

24/10/2013

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

Evexar Medical Ltd

The Network Building 97 Tottenham Court

Road

London, , W1T 4TP

Products

1. Sigmoidoscope, rigid

Product Type

Single Device Product

Effective date

24/10/2013

GMDN

15058 Sigmoidoscope, rigid

Intended purpose

An endoscope intended to be used for observation, diagnosis, and treatment of the large intestine leading

to the rectum. Its insertion portion is rigid and unyielding to body cavities. It is a single use, fully disposable

device that utilises a dedicated separate illuminator inserted into the base of the handle, and a light rod to

direct light to the end of the scope where it is most needed. The device also features a built in insufflator

which enables air expansion of the intestine for more thorough clinical examination when necessary.

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

Page 1 of

Produced at 10.11.2017 at 04:58:42 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