<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09354330000577</udiDi>
    <basicUdiDi>B-09354330000577</basicUdiDi>
    <tradeName>STARGEL10 SATELLITE READER</tradeName>
    <deviceName>STARGEL10 SATELLITE READER</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202030201</emdnCode>
    <emdnDescription>IMMUNOHEMATOLOGY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT2015</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:18.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436583730959</udiDi>
    <basicUdiDi>843658373DGREADERNET77</basicUdiDi>
    <tradeName>DG Reader Net</tradeName>
    <deviceName>DG Reader Net</deviceName>
    <manufacturerName>Diagnostic Grifols, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030201</emdnCode>
    <emdnDescription>IMMUNOHEMATOLOGY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210700</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:45:09.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068491005</udiDi>
    <basicUdiDi>6975068492010020T8</basicUdiDi>
    <tradeName>Dry Fluoroimmunoassay Analyzer</tradeName>
    <deviceName>Dry Fluoroimmunoassay Analyzer</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030201</emdnCode>
    <emdnDescription>IMMUNOHEMATOLOGY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP088.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:03:27.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068490251</udiDi>
    <basicUdiDi>6975068492010010T5</basicUdiDi>
    <tradeName>Dry Fluoroimmunoassay Analyzer</tradeName>
    <deviceName>Dry Fluoroimmunoassay Analyzer</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030201</emdnCode>
    <emdnDescription>IMMUNOHEMATOLOGY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP011.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:03:23.737Z</lastUpdated>
  </row>
</eudamedExport>