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CERTIFICATE

CERTIFICATE

CERTIFICATE

Product catalog summary
Certificate Overview
The document is a certification issued by DEKRA Certification B.V. for Gentherm Medical, LLC, located at 12011 Mosteller Road, Cincinnati, OH, USA. The certificate number is 160366, and it confirms that the management system of the organization meets the ISO 13485:2016 standard.

Scope of Certification
The certification covers the design, manufacture, distribution, and service of devices for therapeutic treatment, measurement, and control of patient temperature.

Certification Details
  • Certificate expiry date: 28 November 2026
  • Certificate effective date: 10 January 2024
  • Certified since: 16 December 2002

Addendum Information
The addendum to the certificate includes an additional location for Gentherm Medical, LLC at Honeymoon Paper Warehouse, 7100 Dixie Highway, Fairfield, OH, USA. This location is certified for finished goods storage and shipping.

Validity
The certificate and its addendum are valid until 28 November 2026, with an effective date of 10 January 2024.
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Catalog excerpts

CERTIFICATE-1

CERTIFICATE Number: 160366 The management system of the organization(s) and locations mentioned on the addendum belonging to: Gentherm Medical, LLC 12011 Mosteller Road Cincinnati, OH 45241 United States of America including the implementation meets the requirements of the standard: ISO 13485:2016 Scope: The design, manufacture, distribution and service of devices for therapeutic treatment, measurement and control of patient temperature. Certificate expiry date: 28 November 2026 Certificate effective date: 10 January 2024 Certified since: 16 December 2002 This certificate is valid for the organization(s) and/or locations mentioned on the addendum. B.T.M. Holtus Managing Director J.M. McKenzie Certification Manager © Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 83000 F +31 88 96 83100 www.dekra-product-safety.com Company registration 09085396

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CERTIFICATE-2

ADDENDUM To certificate: 160366 The management system of the organization(s) and/or location(s) of: Gentherm Medical, LLC 12011 Mosteller Road Cincinnati, OH 45241 United States of America Certified organization(s) and/or locations: Different scope Gentherm Medical, LLC Honeymoon Paper Warehouse 7100 Dixie Highway Fairfield, OH 45014 United States of America Addendum expiry date: Addendum effective date: Finished Goods Storage and Shipping DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 83000 F +31 88 96 83100 www.dekra-product-safety.com...

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