Roechling Medical Lancaster 44 Denver Road Denver, USA 17517 TÜV SÜD Product Service GmbH Your reference/letter of Receipt of formal application To whom it may concern, Confirmation of the status of a formal application in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 (in the following referenced as MDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. With this letter TÜV SÜD Product Service GmbH, designated under MDR and identified by the number 0123 on NANDO, confirms that we have received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR with the above stated manufacturer with the following SRN Number: SRN Number: US-MF-000027642 The devices covered by the formal application mentioned above are identified in the Table below. Please note that this letter only confirms the status of the formal application. To benefit from the additional transitional provisions in the framework of Regulation EU 2023/607, TÜV SÜD Product Service GmbH and the manufacturer need to sign a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR latest until 26 September 2024. In case of inquiries please contact [email protected]. On behalf of the Notified Body TÜV SÜD Product Service GmbH, May 23 2024 TÜV SÜD Product Service GmbH Medical and Health Services Digitally signed by: Soumya Jaganathan DN: CN = Soumya Jaganathan email = soumya. [email protected] C = AD Date: 2024.05.23 17:14:35 -05'00' Soumya Jaganathan Conformity Assessment Responsible (CARE) Devices covered by the formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR

Roechling Medical Lancaster 44 Denver Road Denver, USA 17517 Device name