<?xml version="1.0" encoding="UTF-8"?>
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    <udiDi>04260154344009</udiDi>
    <basicUdiDi>426015434Extended-IPUE8</basicUdiDi>
    <tradeName>04260154344009</tradeName>
    <deviceName>Extended IPU</deviceName>
    <manufacturerName>Sysmex Europe SE</manufacturerName>
    <manufacturerSrn>DE-MF-000022332</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010192</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE004218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:54.306Z</lastUpdated>
  </row>
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    <udiDi>04260154340247</udiDi>
    <basicUdiDi>426015434SP-BufferNM</basicUdiDi>
    <tradeName>04260154340247</tradeName>
    <deviceName>SP-Buffer</deviceName>
    <manufacturerName>Sysmex Europe SE</manufacturerName>
    <manufacturerSrn>DE-MF-000022332</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>370-0030-4</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:53.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260154340445</udiDi>
    <basicUdiDi>426015434SP-BufferNM</basicUdiDi>
    <tradeName>SP-Buffer pH 7.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sysmex Europe SE</manufacturerName>
    <manufacturerSrn>DE-MF-000022332</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>720075112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T15:13:39.910Z</lastUpdated>
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