<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00884883005617</udiDi>
    <basicUdiDi>B-00884883005617</basicUdiDi>
    <tradeName>00884883005617</tradeName>
    <deviceName>CEDIA N-Acetylprocainamide Assay (NAPA)</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>W0102080106</emdnCode>
    <emdnDescription>N-ACETYLPROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:45.701Z</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>00884883000704</udiDi>
    <basicUdiDi>B-00884883000704</basicUdiDi>
    <tradeName>00884883000704</tradeName>
    <deviceName>QMS® Lidocaine (LIDO) Calibrators</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>W0102080105</emdnCode>
    <emdnDescription>LIDOCAINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374678</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:13.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740157517</udiDi>
    <basicUdiDi>8436003070573XU</basicUdiDi>
    <tradeName>Quantia Digitoxin</tradeName>
    <deviceName>Quantia Digitoxin</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6K40-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:20:52.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740153618</udiDi>
    <basicUdiDi>8436003070610X9</basicUdiDi>
    <tradeName>Alinity c Digitoxin Standard</tradeName>
    <deviceName>Alinity c Digitoxin Reagent Kit</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R1101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:20:38.881Z</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>
  <row>
    <udiDi>00380740153625</udiDi>
    <basicUdiDi>8436003070610X9</basicUdiDi>
    <tradeName>Alinity c Digitoxin Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R1110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:36.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740153632</udiDi>
    <basicUdiDi>8436003070610X9</basicUdiDi>
    <tradeName>Alinity c Digitoxin Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R1122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:36.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740157531</udiDi>
    <basicUdiDi>8436003070573XU</basicUdiDi>
    <tradeName>Quantia Digitoxin Standard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6K48-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:35.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740157555</udiDi>
    <basicUdiDi>8436003070573XU</basicUdiDi>
    <tradeName>Quantia Digitoxin Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6K57-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:35.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023262</udiDi>
    <basicUdiDi>0405686901293VM</basicUdiDi>
    <tradeName>Emit® 2000 Procainamide Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080107</emdnCode>
    <emdnDescription>PROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:16.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023279</udiDi>
    <basicUdiDi>0405686901287VS</basicUdiDi>
    <tradeName>Emit® 2000 N-Acetylprocainamide Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080106</emdnCode>
    <emdnDescription>N-ACETYLPROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445323</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:16.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023293</udiDi>
    <basicUdiDi>0405686901298VX</basicUdiDi>
    <tradeName>Emit® 2000 Quinidine Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080109</emdnCode>
    <emdnDescription>QUINIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445329</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:16.269Z</lastUpdated>
  </row>
</eudamedExport>