<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05430001718393</udiDi>
    <basicUdiDi>5430001718BF13000371LU</basicUdiDi>
    <tradeName>CardioCare@Home non linear 24h holter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Byteflies NV</manufacturerName>
    <manufacturerSrn>BE-PR-000033031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CardioCare@Home non linear 24h holter</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:25.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>05350627999979</udiDi>
    <basicUdiDi>B-05350627999979</basicUdiDi>
    <tradeName>Umana T1 Heart Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Umana Medical Technologies Ltd</manufacturerName>
    <manufacturerSrn>MT-MF-000018092</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F-STP002-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:24:40.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974782940929</udiDi>
    <basicUdiDi>697478294holter001PL</basicUdiDi>
    <tradeName>Holter Recorder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan United Imaging Surgical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032693</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>88001252</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:50:38.222Z</lastUpdated>
  </row>
</eudamedExport>