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ISO 13485:2016 Certificate

ISO 13485:2016 Certificate

ISO 13485:2016 Certificate

Product catalog summary
Certificate Overview
This document is a Certificate of Management System issued by Eurofins E&E CML Limited, accredited by the United Kingdom Accreditation Service (UKAS), with registration number 8175. It certifies that Caltag Medsystems Ltd has a Quality Management System that complies with the requirements of EN ISO 13485:2016.
Scope of Certification
The certification covers the design, development, and manufacture of cellular stabilisation reagents for in vitro diagnostic use, as well as the distribution of in vitro diagnostic kits and reagents. It also includes the control of manufacture and distribution of these reagents.
Certification Details
  • Certificate Number: CML QMSMDY2709
  • Issue Number: 5
  • Initial Issue Date: 27th July 2023
  • Current Issue Date: 5th December 2025
  • Expiry Date: 6th August 2028
Certification Schedule
The activities covered under this certification at the location of Caltag Medsystems Ltd, Whiteleaf Business Centre, 11 Little Balmer, Buckingham, MK18 1TF, United Kingdom, include the design, development, and manufacture of cellular stabilisation reagents for in vitro diagnostic use, and the distribution of in vitro diagnostic kits and reagents.
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Catalog excerpts

ISO 13485:2016 Certificate-1

Certificate of Management System Eurofins E&E CML Limited, Newport Business Park, New Port Road, Ellesmere Port CH65 4LZ, UK, accredited by the United Kingdom Accreditation Service (UKAS), registration number 8175, certifies that the Quality Management System of Whiteleaf Business Centre, Has been assessed and found to comply with the requirements of The scope of this certification extends to the following: Design, development and manufacture of cellular stabilisation reagents for in vitro diagnostic use. Distribution of in vitro diagnostic kits and reagents. Control of manufacture and distribution of cellular stabilisation reagents for in vitro diagnostic Certificate Number Issue Number Initial issue date Current issue Expiry 7th August 2022 to 27th July 2023 was covered by another certification body 8175 This Certificate shall only be copied 1 of 2 Cheryl O’Rourke in its entirety and without change Head of Medical Devices - UK Version: 3.0 Approval: Approved

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ISO 13485:2016 Certificate-2

Certification ScheduleLocation_ActivitiesCaltag Medsystems Ltd ISO 13485:2016 Whiteleaf Business Centre, Design, development, and manufacture of cellular 11 Little Balmer, stabilisation reagents for in vitro diagnostic use. Distribution of in vitro diagnostic kits and reagents. This Notification shall only be copied in its entirety and without change

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.