<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07290110252663</udiDi>
    <basicUdiDi>0729011720NM2069202KEYCW</basicUdiDi>
    <tradeName>PC-ECG Option M1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050802</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-M1-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110252625</udiDi>
    <basicUdiDi>0729011720NM2069202KEYCW</basicUdiDi>
    <tradeName>PC-ECG Option I1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050802</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-I1-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110255411</udiDi>
    <basicUdiDi>0729011720NM2069202KEYCW</basicUdiDi>
    <tradeName>PC-ECG Option I3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050802</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-I3-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110252762</udiDi>
    <basicUdiDi>0729011720NM2069202KEYCW</basicUdiDi>
    <tradeName>PC-ECG Option S1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050802</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-S1-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110252779</udiDi>
    <basicUdiDi>0729011720NM2069202KEYCW</basicUdiDi>
    <tradeName>PC-ECG Option S2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050802</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-S2-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258566</udiDi>
    <basicUdiDi>0729011720NM2069202NRSE8</basicUdiDi>
    <tradeName>NR-1207-E</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050101</emdnCode>
    <emdnDescription>STRESS ANALYSIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR1207E-D-00E-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110254896</udiDi>
    <basicUdiDi>0729011720NM2069202NRSE8</basicUdiDi>
    <tradeName>NR-1207-3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050101</emdnCode>
    <emdnDescription>STRESS ANALYSIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR12073-D-00U-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258702</udiDi>
    <basicUdiDi>0729011720NM2069202NRSE8</basicUdiDi>
    <tradeName>NR-1207-3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050101</emdnCode>
    <emdnDescription>STRESS ANALYSIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR12073-D-00E-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258245</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NR-302</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR302-D-00U-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258221</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NR-302</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR302-D-00E-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258344</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NR-314</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR314-D-00U-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258320</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NR-314-P</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR314P-D-00-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258528</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NR-1207</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR1207-D-00U-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258504</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NR-1207</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR1207-D-00E-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110258443</udiDi>
    <basicUdiDi>0729011720NM2069202TELDH</basicUdiDi>
    <tradeName>NR-314-T</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR314T-D-00U-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299794214</udiDi>
    <basicUdiDi>B-08720299794214</basicUdiDi>
    <tradeName>08720299794214</tradeName>
    <deviceName>Multichannel ECG Recorder H4</deviceName>
    <manufacturerName>Systolé Hardware B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000006605</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multichannel Holter ECG Recorder H4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:15:53.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299526495</udiDi>
    <basicUdiDi>B-08720299526495</basicUdiDi>
    <tradeName>EuroSCORE II calculator</tradeName>
    <deviceName>EuroSCORE II calculator</deviceName>
    <manufacturerName>Evidencio</manufacturerName>
    <manufacturerSrn>NL-MF-000008386</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12059092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>570</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:15:49.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299526488</udiDi>
    <basicUdiDi>B-08720299526488</basicUdiDi>
    <tradeName>ATRIA Bleeding Risk Score Calculator</tradeName>
    <deviceName>ATRIA Bleeding Risk Score Calculator</deviceName>
    <manufacturerName>Evidencio</manufacturerName>
    <manufacturerSrn>NL-MF-000008386</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12059092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>155</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:15:43.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299526464</udiDi>
    <basicUdiDi>B-08720299526464</basicUdiDi>
    <tradeName>ORBIT Bleeding Risk Score Calculator</tradeName>
    <deviceName>ORBIT Bleeding Risk Score Calculator</deviceName>
    <manufacturerName>Evidencio</manufacturerName>
    <manufacturerSrn>NL-MF-000008386</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12059092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2496</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:15:30.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682214525023</udiDi>
    <basicUdiDi>B-08682214525023</basicUdiDi>
    <tradeName>Kardinero</tradeName>
    <deviceName>EKG MASTER USB PC ECG SYSTEM</deviceName>
    <manufacturerName>Kardinero Medikal Sistemler Sanayi ve Ticaret A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000014932</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700090</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:20:20.082Z</lastUpdated>
  </row>
</eudamedExport>