<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08436579213671</udiDi>
    <basicUdiDi>843657921PACK4512MDRA7</basicUdiDi>
    <tradeName>Nuubo30_SI_Pack_Box_ 45-12_USA</tradeName>
    <deviceName>Nuubo30 Pack</deviceName>
    <manufacturerName>Smart Solutions Technologies, S.L. (NUUBO)</manufacturerName>
    <manufacturerSrn>ES-MF-000022284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>9384</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:45:02.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613365003888</udiDi>
    <basicUdiDi>76133650000000124Z</basicUdiDi>
    <tradeName>SEMA</tradeName>
    <deviceName>SEMA</deviceName>
    <manufacturerName>SCHILLER AG</manufacturerName>
    <manufacturerSrn>CH-MF-000012722</manufacturerSrn>
    <authorisedRepresentativeName>SCHILLER Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006934</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0A.602010</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:03:52.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350117580029</udiDi>
    <basicUdiDi>7350117580000000004YP</basicUdiDi>
    <tradeName>EC View</tradeName>
    <deviceName>EC View</deviceName>
    <manufacturerName>Cardiolex Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000016895</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CN V</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:59:11.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498562671</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>SW-NEMS-Q</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-Q-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:47.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498562817</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>PC-ECG Option H1</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-H1-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:47.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260498562824</udiDi>
    <basicUdiDi>426049856DE55252NMKEYVQ</basicUdiDi>
    <tradeName>PC-ECG Option I1</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-I1-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:47.096Z</lastUpdated>
  </row>
  <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>
</eudamedExport>