Foetal

Main information

  • Trade name:
  • Foetal Doppler system
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Foetal Doppler system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222078
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222078

Swirl Technologies Pty Ltd T/A Parker Healthcare - Foetal Doppler system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Swirl Technologies Pty Ltd T/A Parker Healthcare

Postal Address

16 Redland Drive,MITCHAM, VIC, 3132

Australia

ARTG Start Date

7/04/2014

Product category

Medical Device Class IIb

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

Shenzhen Comen Medical Instrument Co Ltd

Floor 7 Block 5 4th Industrial Area of Nayou

Nanshan District

Shenzhen, Guangdong, 518052

China

Products

1. Foetal Doppler system

Product Type

Single Device Product

Effective date

7/04/2014

GMDN

34040 Foetal Doppler system

Intended purpose

Comen Obstetric Monitors are intended to monitor physiological parameters of both fetus and pregnant

women during Antepartum, Delivery and Postpartum.

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 02.12.2017 at 04:16:08 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