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:
  • 220526
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220526

Shantex Pty Ltd - Speculum, vaginal, single use

ARTG entry for

Medical Device Included Class Is

Sponsor

Shantex Pty Ltd

Postal Address

PO Box 979,ARCHERFIELD, QLD, 4108

Australia

ARTG Start Date

26/02/2014

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

Taizhou Kangjian Medical Equipment Co Ltd

The Machine Electricity Zone of Yuhuan County

, Zhejiang Province, 317600

China

Products

1. Speculum, vaginal, single use

Product Type

Single Device Product

Effective date

26/02/2014

GMDN

37468 Speculum, vaginal, single use

Intended purpose

Used to provide access to the vagina for examination & cell sample collection.

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 03:50:56 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