Analyser

Main information

  • Trade name:
  • Analyser, fertility, thermometric
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Analyser, fertility, thermometric
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220052
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220052

Hoyland Medical Pty Ltd - Analyser, fertility, thermometric

ARTG entry for

Medical Device Included Class IIa

Sponsor

Hoyland Medical Pty Ltd

Postal Address

Unit 7 / 22 Palmer Place,MURARRIE, QLD, 4172

Australia

ARTG Start Date

12/02/2014

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

Fertility Focus Ltd

Unit 19D University of Warwick Science Park

Warwick Innovation Centre

Warwick Technology Park Gallows Hill Warwick

Warwickshire, , CV34 6UW

Products

1. Analyser, fertility, thermometric

Product Type

Single Device Product

Effective date

12/02/2014

GMDN

36110 Thermometric fertility analyser

Intended purpose

A personal sensor and Reading device is a simple way of establishing when is the best time for women to

fall pregnant. the reading device indicates the tempature of the ladies and when they are ovulation is best

for potential pregnancy.

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 05:30:43 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