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Certificate of Registration

Certificate of Registration

Certificate of Registration

Product catalog summary
Certificate Overview: This document certifies that Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi, located in Ankara, Turkey, holds a Quality Management System certificate compliant with ISO 13485:2016 and EN ISO 13485:2016 standards. The certificate number is MD 77031.
Scope of Certification: The certification covers the design, development, manufacture, installation, and service of PC-based ECG systems and ECG stress test systems with treadmill and accessories.
Certification Details:
  • Original Registration Date: February 11, 2004
  • Effective Date: February 6, 2024
  • Latest Revision Date: January 26, 2024
  • Expiry Date: February 5, 2027
Issuing Authority: The certificate is issued by BSI, represented by Graeme Tunbridge, Senior Vice President Medical Devices. BSI Assurance UK Limited is registered in England and is part of the BSI Group of Companies.
Validation: The certificate is issued electronically and can be authenticated online. Printed copies can be validated at the BSI Client Directory.
Contact Information: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UK. Tel: +44 345 080 9000.
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Catalog excerpts

Certificate of Registration-1

Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 & EN ISO 13485:2016 This is to certify that: Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi Üniversiteler Mah. Ihsan Dogramaci Bulv. No. 29 ODTU Teknokent Gumus Blok BK-7/B Cankaya Ankara 06800 Turkey Holds Certificate Number: and operates a Quality Management System which complies with the requirements of ISO 13485:2016 & EN ISO 13485:2016 for the following scope: The design, development, manufacture, installation and service of PC based ECG systems and ECG stress test systems with treadmill and accessories. For and on behalf of BSI: Graeme Tunbridge, Senior Vice President Medical Devices Original Registration Date: 2004-02-11 Latest Revision Date: 2024-01-26 Expiry Date: 2027-02-05 Page: 1 of 2 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, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A Member of the BSI Group of Companies.

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Certificate of Registration-2

Registered Activities Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi Üniversiteler Mah. Ihsan Dogramaci Bulv. No. 29 ODTU Teknokent Gumus Blok BK-7/B Cankaya Ankara 06800 Turkey The design, development, manufacture, installation and service of PC based ECG systems and ECG stress test systems with treadmill and accessories. Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi Elvan Mahallesi 1918 Sokak No:3/A Etimesgut Ankara 06794 Turkey The design, development, manufacture, installation and service of PC based ECG systems and ECG stress test systems with treadmill and accessories....

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