<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09354330000584</udiDi>
    <basicUdiDi>93543300GT20148V</basicUdiDi>
    <tradeName>STARGEL10 INCUBATOR</tradeName>
    <deviceName>STARGEL10 INCUBATOR</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020399</emdnCode>
    <emdnDescription>BLOOD GROUPING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT2014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:31.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987666543344</udiDi>
    <basicUdiDi>150995901PK74006D</basicUdiDi>
    <tradeName>Beckman Coulter PK7400 Automated Microplate System</tradeName>
    <deviceName>Beckman Coulter PK7400 Automated Microplate System</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020399</emdnCode>
    <emdnDescription>BLOOD GROUPING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B53299</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:42:33.574Z</lastUpdated>
  </row>
</eudamedExport>