certifies that the medical device of Class lla. Electroencephalograph EEG: Type Unique+, Sienna, Sienna ULTIMATE Electromyograph and Evoked Potential Equipment EMG/EP: Type Surpass, Surpass LT Electrical Impedance Segmentograph EIS: Type Angelie EIS Neurostimulator: Type EMS Neurostimulator manufactured by the company Jochingergasse 1, A-2100 Korneuburg, Austria The Notified Body No. 2265 has performed an audit of the above device quality system. The full quality assurance system has been assessed and found that it meets the requirements above. The quality system is subject to continuous surveillance according to Annex II, Sections 3.3, and 5, of the Directive 93/42/EEC as amended by 2007/47/EC. The detailed description of the system, requirements and measures applied by the manufacturer are presented in the Audit Report No. 310376 and the Final protocol No. 310376/2019. This certificate is issued under the following conditions: It applies only to the quality system maintained in the manufacture of the above referenced model of medical device and it does not substitute the design or type-examination procedures, if requested. The certificate remains valid until the manufacturing conditions or the quality system are changed but until April 28, 2024 at the latest. The certificate validity is conditional upon positive results of regular surveillance audits and fulfilment of relevant legal and other requirements by manufacturer. ./ Dr. Katarina Tomin Srdosova 'esponsible to act on behalf of NB 2265

3 EC 3EC International a.s., Hranicna 18, 821 05 Bratislava, Slowakei Nr. 2019-MDD/QS-036 in Ubereinstimmung mit der Richtlinie 93/42/EWG in der Fassung 2007/47/EG, die als slowakische Regierungsverordnung Nr 582/2008 umgesetzt und durch Fassung 215/2013 erganzt wurde, bestatigt hiermit, dass die Medizinprodukte der Klasse Ha. Elektroenzephalograph EEG: Typ Unique+, Sienna, Sienna ULTIMATE Elektromyograph und Evozierte Potentiate Gerat EMG / EP: Elektrische Impedanz Segmentograph EIS: Typ Angelie EIS Neurostimulator: Typ EMS Neurostimulator EMS Handels Gesellschaft m.b.H. Jochingergasse 1, A-2100...

in relation to 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, in particular with respect to • the validity of certificates issued under Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MDD) (Directive Certificates) and/or1 • the compliance of the devices and us as their manufacturer with the conditions for the continued placing on the market and putting into service 1 The first condition...

We, as the manufacturer declare under our sole responsibility: • for the above listed Directive Certificate (or see attached schedule, if multiple certificates) the conditions for the legal extension of validity as required in Article 120.2 of the MDR are met and/or1 • the listed device(s) in the attached schedule and we as their manufacturer are in compliance with the conditions listed in Article 120.3c of the MDR for continued placing on the market and putting into service, namely by fulfilling the following conditions: > Directive Certificate(s) as listed above or in the attached schedule...

□ A Competent Authority has required the manufacturer, in accordance with Article 97(1) MDR, to carry out the applicable conformity assessment procedure (may be provided upon request) Choose one of the following statements only if a derogation per Article 59(1) ora requirement per Article 97(1) has been granted by a Competent Authority: □ Formal application(s) to the notified body in accordance with Section 4.3, first subparagraph of Annex VII MDR for conformity assessment has/have been made or will be made/submitted by us to a notified body no later than 26 May 2024 for the device(s) listed...

Choose one applicable statement: □ A QMS in accordance with Article 10(9) MDR will be put in place by no later than 26 May 2024. 0 A QMS in accordance with Article 10(9) MDR is in place. > Device(s) as listed in the attached schedule • The device(s) continue to comply with the AIMDD or MDD. • There are no significant changes in the design and intended purpose. • The device(s) do not present an unacceptable risk to health or safety of patients, users or other persons, or to other aspects of the protection of public health. Signed for and on behalf of the manufacturer: EMS Handels Gesellschaft...

J for devices with AIMDD/MDD certificate(s) the identification should be as in the certificate, and only if the certificate has a generic scope it should be as defined

Attn. Alfred Ortner/ Chief Executive Officer Our reference Contact person BRATISLAVA Subject: Notified Body Confirmation Letter 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 amended as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices This letter confirms that, 3EC International a.s., a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number 2265 on...

• 31 December 2027 for Class III devices and Class lib implantable devices excluding Well-established technologies (WET - sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) • 31 December 2028 for other Class lib devices, Class lla, Class I devices placed on the market in sterile condition or have a measuring function • 31 December 2028 for devices not requiring the involvement of a notified body under MDD but requiring it under MDR (e g., class I devices that qualify as re-usable surgical instruments) On behalf of the Notified...