SLG Pruf- und Zertifizierungs GmbH Unser Zeichen Bearbeiter Datum (E-Mail: [email protected]) Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices This letter confirms that, SLG Pruf- und Zertifizierungs GmbH, a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number NB 0494 on NANDO, has received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the following manufacturer: Von Ardenne Institut fur Angewandte Medizinische Forschung GmbH SLG Pruf- und Zertifizierungs GmbH Burgstadter Str. 20 09232 Hartmannsdorf T + 49 3722 7323 - 0 F + 49 3722 7323 - 899 E [email protected] I www.slg.de.com Dipl.-Ing. Kay-Uwe Schult Dipl.-Ing. Thomas Frank Bettina Hahnel Kuhnert Deutsche Bank AG Chemnitz VAT-ID DE 140 855 197 Sparkasse Chemnitz

The devices covered by the formal application and the written agreement mentioned above are identified in the Tables below. Table 1 identifies the devices for which an MDR application has been received, written agreement concluded and for which the NB is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive. Table 2 identifies the devices for which an MDR application has been received and a written agreement concluded, but the NB has not yet taken the responsibility for appropriate surveillance of the corresponding devices under the applicable...

SLG Pruf- und Zertifizierungs GmbH Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive:

SLG Pruf- und Zertifizierungs GmbH Confirmation Letter Revision History Date