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Iso 13485

HORIBA ABX SAS has been certified with Certificate Number MD 730428 for its Quality Management System compliant with ISO 13485:2016 & EN ISO 13485:2016. The certification covers the design, development, manufacture, distribution, and sales of in vitro test kits and diagnostic analyzers. The certificate was originally registered on January 15, 2021, and is valid until October 17, 2024.

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25 views2 pages

Iso 13485

HORIBA ABX SAS has been certified with Certificate Number MD 730428 for its Quality Management System compliant with ISO 13485:2016 & EN ISO 13485:2016. The certification covers the design, development, manufacture, distribution, and sales of in vitro test kits and diagnostic analyzers. The certificate was originally registered on January 15, 2021, and is valid until October 17, 2024.

Uploaded by

bluesky.ngochanguyen
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Certificate of Registration

QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 & EN ISO 13485:2016

This is to certify that: HORIBA ABX SAS


Parc Euromédecine
Rue du Caducée
BP 7290
Montpellier Cedex 4
34184
France

Holds Certificate Number: MD 730428


and operates a Quality Management System which complies with the requirements of ISO 13485:2016 & EN ISO
13485:2016 for the following scope:

Design, development, manufacture, distribution and sales of in vitro test kits, in vitro
diagnostic reagents, in vitro diagnostic analyzers and accessories used in the diagnosis and
management of disease status, blood analytes, blood components, hemostasis.
Installation and servicing activities of in vitro diagnostic analyzers.

For and on behalf of BSI:


Gary E Slack, Senior Vice President - Medical Devices

Original Registration Date: 2021-01-15 Effective Date: 2021-10-18


Latest Revision Date: 2022-01-27 Expiry Date: 2024-10-17

Page: 1 of 1

This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory

Information and Contact:


BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.

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