EU-DECLARATION OF CONFORMITY 05/23
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EU-DECLARATION OF CONFORMITY 05/23
Product catalog summary
Declaration Overview: X-CEN-TEK GmbH & Co. KG declares that their medical devices under the product group 'PAX Rescue & Transport Systems' comply with Regulation (EU) 2017/745 (MDR) and other relevant Union legislation. The declaration is valid until May 25, 2024.
Product Details: The product group includes devices such as the PAX Spineboard harness system, intended for the rescue and transport of injured and sick persons. These are classified as class 1 medical devices according to Annex VIII, Rule 1 MDR.
Compliance and Standards: The devices meet essential safety and performance requirements as per Annex I MDR. A conformity assessment procedure has been conducted according to Annex II & III MDR. The applicable standards include EN ISO 13485 for quality management systems, EN ISO 14971 for risk management, and EN 1865-1 for patient handling equipment in road ambulances.
Certification and Validity: The declaration is signed by Dr. Nils-Lasse Schneider, PRRC according to Art.15 MDR, and is valid until May 25, 2024. The manufacturer's SRN is DE-MF-000009521.
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Catalog excerpts
EU - Declaration of Conformity We, X-CEN-TEK GmbH & Co. KG, Westerburger Weg 30 - D-26203 Wardenburg, declare under our sole responsibility that the medical devices of the product group PAX Rescue & Transport Systems Basic UDI-DI: 426074548 016018020019 MJ complies with the relevant provisions of Regulation (EU) 2017/745 (MDR) on medical devices and, where applicable, other relevant Union legislation
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