CPAP BiPAP

Main information

  • Trade name:
  • CPAP/BiPAP face mask, reusable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CPAP/BiPAP face mask, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217894
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217894

McFarlane Medical Equipment (Holdings) Pty Ltd - CPAP/BiPAP face mask, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

McFarlane Medical Equipment (Holdings) Pty Ltd

Postal Address

443 Canterbury Road,SURREY HILLS, VIC, 3127

Australia

ARTG Start Date

29/11/2013

Product category

Medical Device Class 1

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

Ningbo Greetmed Medical Instruments Co Ltd

18F-3 No 1 Building No 487 Yangmuqi Road

Ningbo, , 315042

China

Products

1. CPAP/BiPAP face mask, reusable

Product Type

Single Device Product

Effective date

29/11/2013

GMDN

57814 CPAP/BiPAP face mask, reusable

Intended purpose

Mask to protect nose from breathing in outer particles, and to protect mouth from breathing out particles

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 12:37:06 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