Instrument/analyser IVDs

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
BGI Health (AU) Company Pty Ltd
Class:
Class 1
Authorization status:
Included - IVD
Authorization number:
339716

Public Summary

Summary for ARTG Entry:

339716

BGI Health (AU) Company Pty Ltd - Instrument/analyser IVDs

ARTG entry for

Medical Device Included - IVD Class 1

Sponsor

BGI Health (AU) Company Pty Ltd

Postal Address

Level 6 CBCRC building 300 Herston Road, Herston, QLD, 4006

Australia

ARTG Start Date

17/07/2020

Product Category

Medical Device Class 1

Status

Active

Approval Area

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

Hunan Xiangyi Laboratory Instrument

Development Co Ltd

No 35 Jinsui Road Wangcheng Economic

Development Zone

Changsha, Hunan,

China

Products

1 . Instrument/analyser IVDs

Product Type

Effective Date

17/07/2020

GMDN

CT943 Instrument/analyser IVDs

Intended Purpose

To separate, condense and purify matter using centrifugal settling.

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 22.07.2020 at 08:38:30 AEST

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

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