Instrument/analyser IVDs

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

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Public Summary

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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.

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