<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00884883008199</udiDi>
    <basicUdiDi>B-00884883008199</basicUdiDi>
    <tradeName>00884883008199</tradeName>
    <deviceName>ARCHITECT Digoxin Calibrator</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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1E06-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:57.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008182</udiDi>
    <basicUdiDi>B-00884883008182</basicUdiDi>
    <tradeName>00884883008182</tradeName>
    <deviceName>ARCHITECT Digoxin Reagent Kit</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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1E06-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:57.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001206</udiDi>
    <basicUdiDi>B-00884883001206</basicUdiDi>
    <tradeName>00884883001206</tradeName>
    <deviceName>DRI Digoxin 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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1669</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:03.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975182500232</udiDi>
    <basicUdiDi>697518250P114015Y</basicUdiDi>
    <tradeName>Digoxin Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Digoxin Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:53.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590599</udiDi>
    <basicUdiDi>697518250F114082C</basicUdiDi>
    <tradeName>Digoxin CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Digoxin CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11408</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:29:41.338Z</lastUpdated>
  </row>
</eudamedExport>