EC CERTIFICATEFull Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding (4) The NEOEMKI National Medical Device Conformity Assessment and Certification LLC. certifies that the manufacturer: for the products / product category: ECG systems with Cardiospy softwer for non-invasive cardiology diagnostics applies a quality system which meets the requirements of Directive 93/42/EEC concerning medical devices, Annex II. Registry number of the related audit report: NE/1043/2020 This certificate is valid until 2023-06-15 supposed that the results of the regular yearly surveillance audits are satisfactory. Issued by NEOEMKI LLC as a Notified Body with identification number 1011. This certificate is valid only with the attachment. First issued by the Directorate of Device Testing and Clinical Engineering (EMKI) on 16 June 2018. Budapest, 2020-07-28 iIj The authenticity and validity of the certificate are verifiable at NEOEMKI LLC. neoEMKI Nemzeti Orvostechnikai Eszkoz Megfelelosegertekelo es Tanusito Kft. neoEMKI National Medical Device Conformity Assessment and Certification LLC. H-1097 Budapest, Albert Florian ut 3/A, tel: +36 20 268 75 95, e-mail: cert(a)emki.hu www.emki.hu

ATTACHMENT TO EC CERTIFICATE Page 1 of 1 Additional information for Certificate No. 5-850-200-1806 The certificate is valid for the following Ha class products / models: ECG systems with Cardiospy softwer for non-invasive cardiology diagnostics EC type Holter systems with “Cardiospy” software EC type resting and stress test ECG systems with “Cardiospy” software neoEMKI Nemzeti Orvostechnikai Eszkoz Megfelelosegertekelo esTanusito Kft. neoEMKI Notional Medical Device Conformity Assessment and Certification LLC. H-1097 Budapest, Albert Florian ut 3/A, tel: +36 20 268 75 95, e-mail: cert(g)emki.hu...