> DEKRA EC CERTIFICATfor the Quality Assurance according the Directive Annex \\ excluding section (4) As a Notified Body of the European Union, DEKRA Stihler Electronic Gaussstrasse 4, 70771 Leinfeld Certified location: applies a quality assurance system according to the Directive 93/42/EEC Annex II for the medical devices listed in the annex. The approval is based on the result of the re-certification audit report no. 50192-Z6-00, the decision dated 2020-11-20 and is only valid in connection with the successful performance of the annual surveillance audits. This certificate is valid from 2020-11-20 to 2023-08-17 Zentralstelle der Lander •§ fOr Gesundheitsschutz bei Arzneimitteln und g Medizinprodukten I Ruth Delbed DEKRA Certification GmbH Stuttgart; 2020-11-20 Notified Body ID-number: 0124 DEKRA Certification GmbH * HandwerkstrafBe 15 * D-70565 Stuttgart * www.dekra.de/audits

Annex to the EC Certificate No. 50192-16-06 > DEKRA Valid from 2020-11 -20 to 2023-08-17 Revision status of the annex: 0 dated 2020-11 -20 Devices/device categories included in the certificate: Patient Warming System Product name / Product description ASTOPAD® Patient Warming System ASTOPAD® DUO310 / Control unit (incl. REF 1831.0001, Built-in, rechargeable battery for ASTOPAD DUO310 control unit (optional)) ASTOPAD® COV / Heated blanket ASTOPAD® SOF / Heated, pressure-relieving OR table cushion ASTOPAD® ROE heated, pressure relieving OR table mattress Warmer for Blood, Intravenous Fluids and...

DEKRA Certification GmbH Contact Karin Heckel Email [email protected] DEKRA Certification GmbH - HandwerkstraBe 15 - D -70565 Stuttgart Stihler Electronic GmbH Mr Jens-Peter Weege Gaussstrasse 4 Subject: Notified Body Confirmation Letter Our reference: 50192-CoL-01, Rev. 0 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 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices This letter confirms that, DEKRA...

procedure in accordance with Article 59(1) of MDR or Article 97(1) of the MDR respectively, by the 20 Mar 2023 for the relevant devices. The transition timelines that apply to the devices covered by this letter, subject to the manufacturer’s continued compliance to the other conditions specified in Article 120.3c of MDR (as amended by (EU) 2023/607), are shown below: • 26 May 2026 for Class III custom-made implantable devices • 31 December 2027 for Class III devices and Class lib implantable devices excluding Well-established technologies (WET - sutures, staples, dental fillings, dental braces,...

Table 1: Devices covered by this letter and for which the notified body DEKRA Certification GmbH is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive: DEKRA Certification GmbH * HandwerkstralJe 15 * D-70565 Stuttgart * www.dekra-certification.de/medizinprodukte

DEKRA Certification GmbH - HandwerkstraBe 15 - D-70565 Stuttgart Stihler Electronic GmbH Mr Moritz Freimut Gaussstrasse 4 70771 Leinfelden-Echterdingen Germany DEKRA Certification GmbH Contact Karin Heckel Email [email protected] Decision concerning your change notification no. 501952-CN22-03: Discontinuation of the product (Phase Out) PRISMATHERMII, cl. lib as of2022-12-31, article no: P2XEU (109820), P2XUK (109821), P2XCN (113222) Decision concerning your change notification 501952-CN23-01: Discontinuation of the product (Phase Out) PRISMAFLO IIS, cl. lib as of2023-08-17; article nos....