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CERTIFICATE

CERTIFICATE
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CERTIFICATE

Product catalog summary
Certificate Overview
DEKRA Certification GmbH has issued a certificate to Stihler Electronic GmbH, confirming compliance with the EN ISO 13485:2016 + AC:2018 + A11:2021 standards. This certification pertains to the quality management system established by the organization.
Scope of Certification
The certification covers the design, production, and distribution of devices aimed at preventing hypothermia and decubitus, as well as accessories and diaphanoscopes for transillumination.
Certified Location
The certified location is Gaussstrasse 4, 70771 Leinfelden-Echterdingen, Germany.
Audit and Certification Details
The conformity was verified through audit report no. 50192-Z7-00. The certificate registration number is 50192-21-00_EN. The previous certificate is valid until 2024-05-23, and the current certificate is valid from 2024-05-24 to 2026-07-23.
Certification Authority
The certificate was issued by Karin Leicht from DEKRA Certification GmbH, Stuttgart, on 2024-05-24.
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Catalog excerpts

CERTIFICATE-1

EN ISO 13485:2016 + AC:2018 + A11:2021 DEKRA Certification GmbH hereby certifies that the organization Stihler Electronic GmbH Scope of certification: Design, production and distribution of devices for hypothermia and decubitus prevention and accessories and diaphanoscopes for transillumination. Certified location: Gaussstrasse 4, 70771 Leinfelden-Echterdingen, Germany has established and maintains a quality management system according to the above mentioned standard. The conformity was adduced with audit report no. 50192-Z7-00. Certificate registration no.: 50192-21-00_EN Validity of previous certificate: 2024-05-23 Certificate valid from: Certificate valid to: Karin Leicht DEKRA Certification GmbH, Stuttgart, 2024-05-24 DEKRA Certification GmbH * Handwerkstraße 15 * D-70565 Stuttgart * www.dekra-certification.de/medizinprodukte

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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.