<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260498562855</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>PC-ECG Option I3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>STRESS ANALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-I3-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:47.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498562862</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>PC-ECG Option L1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>STRESS ANALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-L1-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:47.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498562879</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>PC-ECG Option M1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>STRESS ANALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-M1-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:46.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498562978</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>SW-NH-301</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>CARDIOVASCULAR HOLTER ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-NH301-Net-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:46.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498562992</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>SW-NM-700</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-NM700BT-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:46.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498563012</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>PC-ECG Option S1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>STRESS ANALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-S1-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:46.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498563029</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>PC-ECG Option S2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>STRESS ANALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-S2-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:46.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498568192</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>SW-NEMS-Web</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HASP-SW-K-NEMS-WEB-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:20.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413848016</udiDi>
    <basicUdiDi>69444138SmartECGWebYP</basicUdiDi>
    <tradeName>ECG Analysis Software</tradeName>
    <deviceName>ECG Analysis Software</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Smart ECG Web</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:09.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413829008</udiDi>
    <basicUdiDi>69444138AIHolterW5</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI Holter</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:30:42.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413814301</udiDi>
    <basicUdiDi>69444138AISEMIPV3</basicUdiDi>
    <tradeName>ECG Analysis Software</tradeName>
    <deviceName>ECG Analysis Software</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI-SEMIP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:16.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413814295</udiDi>
    <basicUdiDi>69444138AISEMIPV3</basicUdiDi>
    <tradeName>ECG Analysis Software</tradeName>
    <deviceName>ECG Analysis Software</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-1818</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:14.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413814288</udiDi>
    <basicUdiDi>69444138AISEMIPV3</basicUdiDi>
    <tradeName>ECG Analysis Software</tradeName>
    <deviceName>ECG Analysis Software</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Intelligent ECG Platform</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:13.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413814271</udiDi>
    <basicUdiDi>69444138AISEMIPV3</basicUdiDi>
    <tradeName>ECG Analysis Software</tradeName>
    <deviceName>ECG Analysis Software</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>smart ECG Net</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:07.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024670080</udiDi>
    <basicUdiDi>3770024670RBH01P00004C</basicUdiDi>
    <tradeName>R-One Robotplatform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ROBOCATH S.A.S</manufacturerName>
    <manufacturerSrn>FR-MF-000003651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBH01P0000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:24.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024670127</udiDi>
    <basicUdiDi>3770024670RBH01P00004C</basicUdiDi>
    <tradeName>R-One Robotplatform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ROBOCATH S.A.S</manufacturerName>
    <manufacturerSrn>FR-MF-000003651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBH01P0000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:24.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024670134</udiDi>
    <basicUdiDi>3770024670RBH01P00004C</basicUdiDi>
    <tradeName>R-One Robotic Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ROBOCATH S.A.S</manufacturerName>
    <manufacturerSrn>FR-MF-000003651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBH01P0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:24.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024670226</udiDi>
    <basicUdiDi>3770024670RBH01C0000XS</basicUdiDi>
    <tradeName>Kit Consommable R-One</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ROBOCATH S.A.S</manufacturerName>
    <manufacturerSrn>FR-MF-000003651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBH01C0000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:24.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024670240</udiDi>
    <basicUdiDi>3770024670RBH01P00004C</basicUdiDi>
    <tradeName>R-One Robotplatform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ROBOCATH S.A.S</manufacturerName>
    <manufacturerSrn>FR-MF-000003651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBH01P0000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:24.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024670257</udiDi>
    <basicUdiDi>3770024670RBH01P00004C</basicUdiDi>
    <tradeName>R-One Robotplatform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ROBOCATH S.A.S</manufacturerName>
    <manufacturerSrn>FR-MF-000003651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBH01P0000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:24.237Z</lastUpdated>
  </row>
</eudamedExport>