Centrifuge

Main information

  • Trade name:
  • Centrifuge, general-purpose laboratory
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Centrifuge, general-purpose laboratory
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220976
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220976

Samson Medical Technologies Pty Ltd - Centrifuge, general-purpose laboratory

ARTG entry for

Medical Device Included Class 1

Sponsor

Samson Medical Technologies Pty Ltd

Postal Address

Po Box 559,Kellyville, NSW, 2155

Australia

ARTG Start Date

11/03/2014

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

Gyrozen Co Ltd

1F 554-1 Bongmyeong-dong

Yuseong-gu, Daejeon,

Korea - Republic of

Products

1. Centrifuge, general-purpose laboratory

Product Type

Medical device system

Effective date

11/03/2014

GMDN

36465 Centrifuge, general-purpose laboratory

Intended purpose

A general-purpose laboratory centrifuge used to separate the components of suspensions by the

centrifugal force. This device is intended to centrifuge patient samples, either alone or after addition of

reagents or other additives.

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 02:33:52 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