Speculum

Main information

  • Trade name:
  • Speculum, vaginal, single use
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Speculum, vaginal, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222146
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222146

Medical Industries Australia - Speculum, vaginal, single use

ARTG entry for

Medical Device Included Class Is

Sponsor

Medical Industries Australia

Postal Address

512 Creek Street,ALBURY, NSW, 2640

Australia

ARTG Start Date

8/04/2014

Product category

Medical Device Class Is

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

Changzhou Shunfeng Plastic Co Ltd.

Shunbei Country Zhenglu Town Wujin Area

Changzhou City, Jiangsu Province, 213116

China

Products

1. Speculum, vaginal, single use

Product Type

Single Device Product

Effective date

8/04/2014

GMDN

37468 Speculum, vaginal, single use

Intended purpose

This is a hand held device that is intended to be used during examination and treatment of the vagina for

the purpose of providing access to the interior, usually by expanding/distending the opening to this orifice.

This device has built-in lighting for improve visualisation. This device is disposable.

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 09.11.2017 at 10:37:55 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