<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15099590220242</udiDi>
    <basicUdiDi>150995905IM36796Z</basicUdiDi>
    <tradeName>Cyclosporine direct RIA KIT</tradeName>
    <deviceName>Cyclosporine direct RIA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3679</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:45:47.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CsA706-AEB2</udiDi>
    <basicUdiDi>B-CsA706-AEB2</basicUdiDi>
    <tradeName>CsA Cyclosporine(CLIA)</tradeName>
    <deviceName>CsA Cyclosporine(CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CsA706-AE10Y, CsA706-AE10N, CsA706-AE20Y, CsA706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:34.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001589</udiDi>
    <basicUdiDi>B-00884883001589</basicUdiDi>
    <tradeName>00884883001589</tradeName>
    <deviceName>CEDIA CsA PLUS Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100147</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:09.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001299</udiDi>
    <basicUdiDi>B-00884883001299</basicUdiDi>
    <tradeName>00884883001299</tradeName>
    <deviceName>CEDIA Cyclosporine PLUS High Range Calibrators (450/2000)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:14.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501457</udiDi>
    <basicUdiDi>B-06947145501457</basicUdiDi>
    <tradeName>MAGLUMI CSA (CLIA)</tradeName>
    <deviceName>CSA (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130207001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:33.800Z</lastUpdated>
  </row>
</eudamedExport>