<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08437020286053</udiDi>
    <basicUdiDi>8437020286NedRodilla_PSS2</basicUdiDi>
    <tradeName>NedRodilla/IBV</tradeName>
    <deviceName>NedRodilla/IBV</deviceName>
    <manufacturerName>ASOCIACIÓN INSTITUTO DE BIOMECÁNICA DE VALENCIA (I.B.V.)</manufacturerName>
    <manufacturerSrn>ES-MF-000004011</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NedRodilla/PS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:07:22.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437020286046</udiDi>
    <basicUdiDi>8437020286NedHombro_PSPE</basicUdiDi>
    <tradeName>NedHombro/IBV</tradeName>
    <deviceName>NedHombro/IBV</deviceName>
    <manufacturerName>ASOCIACIÓN INSTITUTO DE BIOMECÁNICA DE VALENCIA (I.B.V.)</manufacturerName>
    <manufacturerSrn>ES-MF-000004011</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NedHombro_PS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:07:21.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437020286039</udiDi>
    <basicUdiDi>8437020286NedCervicalPSJ2</basicUdiDi>
    <tradeName>NedCarvical/IBV</tradeName>
    <deviceName>NedCervical/IBV</deviceName>
    <manufacturerName>ASOCIACIÓN INSTITUTO DE BIOMECÁNICA DE VALENCIA (I.B.V.)</manufacturerName>
    <manufacturerSrn>ES-MF-000004011</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NedCervical_PS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:07:20.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437020286022</udiDi>
    <basicUdiDi>8437020286NedLumbar_PSQN</basicUdiDi>
    <tradeName>NedLumbar/IBV</tradeName>
    <deviceName>NedLumbar/IBV</deviceName>
    <manufacturerName>ASOCIACIÓN INSTITUTO DE BIOMECÁNICA DE VALENCIA (I.B.V.)</manufacturerName>
    <manufacturerSrn>ES-MF-000004011</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NedLumbar_PS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:07:19.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437020286015</udiDi>
    <basicUdiDi>8437020286NedMano_PSBD</basicUdiDi>
    <tradeName>NedMano/IBV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASOCIACIÓN INSTITUTO DE BIOMECÁNICA DE VALENCIA (I.B.V.)</manufacturerName>
    <manufacturerSrn>ES-MF-000004011</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NedMano_PS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:07:15.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055774030168</udiDi>
    <basicUdiDi>805577403SYLOGYU4</basicUdiDi>
    <tradeName>SYLOGY</tradeName>
    <deviceName>SYLOGY</deviceName>
    <manufacturerName>Tesi Elettronica e Sistemi Informativi S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000021278</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYLOGY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:02.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649993906017</udiDi>
    <basicUdiDi>7649993906NUTTH</basicUdiDi>
    <tradeName>07649993906017</tradeName>
    <deviceName>Oviva App</deviceName>
    <manufacturerName>Oviva AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019928</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Oviva App iOS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:54:06.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090068750002</udiDi>
    <basicUdiDi>709006875000CJ</basicUdiDi>
    <tradeName>07090068750002</tradeName>
    <deviceName>Braive Therapy</deviceName>
    <manufacturerName>Braive AB</manufacturerName>
    <manufacturerSrn>SE-MF-000048048</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.0</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:17:22.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974687731820</udiDi>
    <basicUdiDi>697468773XA01TC</basicUdiDi>
    <tradeName>μFR</tradeName>
    <deviceName>Quantitative Flow Ratio Analysis Software</deviceName>
    <manufacturerName>Shanghai Pulse Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000033837</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:24.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974687731622</udiDi>
    <basicUdiDi>697468773CT01RQ</basicUdiDi>
    <tradeName>CT-μFR</tradeName>
    <deviceName>CCTA-Derived Fractional Flow Reserve Analysis Software</deviceName>
    <manufacturerName>Shanghai Pulse Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000033837</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:23.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974687731516</udiDi>
    <basicUdiDi>697468773IVUS015Z</basicUdiDi>
    <tradeName>UFR</tradeName>
    <deviceName>IVUS-Derived Fractional Flow Reserve Analysis Software</deviceName>
    <manufacturerName>Shanghai Pulse Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000033837</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:22.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974687731226</udiDi>
    <basicUdiDi>697468773OCT01UA</basicUdiDi>
    <tradeName>OctPlus</tradeName>
    <deviceName>OCT-Derived Fractional Flow Reserve Analysis Software</deviceName>
    <manufacturerName>Shanghai Pulse Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000033837</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:19.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905753795003</udiDi>
    <basicUdiDi>59057537950ABAStrokeUC</basicUdiDi>
    <tradeName>ABAStroke Aplikacja Mobilna</tradeName>
    <deviceName>ABAStroke</deviceName>
    <manufacturerName>ABAStroke Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000039172</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.0.2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:11:10.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904915721003</udiDi>
    <basicUdiDi>5904915721CVMedCP</basicUdiDi>
    <tradeName>Customy Vision</tradeName>
    <deviceName>Customy Vision</deviceName>
    <manufacturerName>Smart Labs Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000022556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:02:34.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903021560742</udiDi>
    <basicUdiDi>590302156DRAI23K</basicUdiDi>
    <tradeName>DeepRhythmAI</tradeName>
    <deviceName>DeepRhythmAI</deviceName>
    <manufacturerName>Medicalgorithmics S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000011413</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>05903021560742</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:30:10.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903021560681</udiDi>
    <basicUdiDi>590302156DRPlatform2WF</basicUdiDi>
    <tradeName>DeepRhythm Platform</tradeName>
    <deviceName>DeepRhythm Platform</deviceName>
    <manufacturerName>Medicalgorithmics S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000011413</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>05903021560681</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:30:09.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903021560230</udiDi>
    <basicUdiDi>590302156DRPlatformMF</basicUdiDi>
    <tradeName>DeepRhythm Platform</tradeName>
    <deviceName>DeepRhythm Platform</deviceName>
    <manufacturerName>Medicalgorithmics S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000011413</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>05903021560230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:30:07.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903021560186</udiDi>
    <basicUdiDi>590302156PCClientFD</basicUdiDi>
    <tradeName>PC Client</tradeName>
    <deviceName>PocketECG PC Client</deviceName>
    <manufacturerName>Medicalgorithmics S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000011413</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05903021560186</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:30:06.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903021560131</udiDi>
    <basicUdiDi>590302156DRAI8R</basicUdiDi>
    <tradeName>DeepRhythmAI</tradeName>
    <deviceName>DeepRhythmAI</deviceName>
    <manufacturerName>Medicalgorithmics S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000011413</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>05903021560131</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:30:05.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>00142700048958</udiDi>
    <basicUdiDi>42700048958000JC</basicUdiDi>
    <tradeName>Mika</tradeName>
    <deviceName>Mika</deviceName>
    <manufacturerName>Outcomes4Me Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000047824</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.0.x</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:42:23.044Z</lastUpdated>
  </row>
</eudamedExport>