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<eudamedExport entity="devices">
  <row>
    <udiDi>04050598007789</udiDi>
    <basicUdiDi>B-04050598007789</basicUdiDi>
    <tradeName>IDK® TurbiCAL®</tradeName>
    <deviceName>IDK® TurbiCAL®</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU1021.1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:33.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598007741</udiDi>
    <basicUdiDi>B-04050598007741</basicUdiDi>
    <tradeName>IDK® TurbiPEL®</tradeName>
    <deviceName>IDK® TurbiPEL®</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060303</emdnCode>
    <emdnDescription>PANCREAS-ELASTASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU1011.8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:33.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598007734</udiDi>
    <basicUdiDi>B-04050598007734</basicUdiDi>
    <tradeName>IDK® TurbiPEL®</tradeName>
    <deviceName>IDK® TurbiPEL®</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060303</emdnCode>
    <emdnDescription>PANCREAS-ELASTASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU1011.2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:32.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598007727</udiDi>
    <basicUdiDi>B-04050598007727</basicUdiDi>
    <tradeName>IDK® TurbiPEL®</tradeName>
    <deviceName>IDK® TurbiPEL®</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060303</emdnCode>
    <emdnDescription>PANCREAS-ELASTASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU1011.1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:31.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006294</udiDi>
    <basicUdiDi>B-04050598006294</basicUdiDi>
    <tradeName>IDK® anti-SARS-CoV-2 IgM ELISA</tradeName>
    <deviceName>IDK® anti-SARS-CoV-2 IgM ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 5001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:26.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006270</udiDi>
    <basicUdiDi>B-04050598006270</basicUdiDi>
    <tradeName>IDK® Serotonin ELISA</tradeName>
    <deviceName>IDK® Serotonin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039011</emdnCode>
    <emdnDescription>SEROTONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6881</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:25.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006263</udiDi>
    <basicUdiDi>B-04050598006263</basicUdiDi>
    <tradeName>GABA ELISA</tradeName>
    <deviceName>GABA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:25.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006249</udiDi>
    <basicUdiDi>B-04050598006249</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 1, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1927-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:24.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006232</udiDi>
    <basicUdiDi>B-04050598006232</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 1, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG192796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:20.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006201</udiDi>
    <basicUdiDi>B-04050598006201</basicUdiDi>
    <tradeName>MutaPLATE® Aldolase B™</tradeName>
    <deviceName>MutaPLATE® Aldolase B™</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF190432</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:19.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006188</udiDi>
    <basicUdiDi>B-04050598006188</basicUdiDi>
    <tradeName>IDK® anti-SARS-CoV-2 IgG ELISA</tradeName>
    <deviceName>IDK® anti-SARS-CoV-2 IgG ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 5000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:18.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006164</udiDi>
    <basicUdiDi>B-04050598006164</basicUdiDi>
    <tradeName>IDKmonitor® Infliximab drug level</tradeName>
    <deviceName>IDKmonitor® Infliximab drug level</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9655.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:17.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006157</udiDi>
    <basicUdiDi>B-04050598006157</basicUdiDi>
    <tradeName>IDKmonitor® Adalimumab drug level ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab drug level ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9657.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:13.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006027</udiDi>
    <basicUdiDi>B-04050598006027</basicUdiDi>
    <tradeName>MutaPLEX® Coronavirus</tradeName>
    <deviceName>MutaPlex® Coronavirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1926-768</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:12.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006010</udiDi>
    <basicUdiDi>B-04050598006010</basicUdiDi>
    <tradeName>MutaPlex® Coronavirus, PCR</tradeName>
    <deviceName>MutaPlex® Coronavirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1926-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:11.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598005969</udiDi>
    <basicUdiDi>B-04050598005969</basicUdiDi>
    <tradeName>MutaPlex® Coronavirus, PCR</tradeName>
    <deviceName>MutaPlex® Coronavirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG192696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:10.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598005891</udiDi>
    <basicUdiDi>B-04050598005891</basicUdiDi>
    <tradeName>MutaPLATE® Aldolase B (A174D)™</tradeName>
    <deviceName>MutaPLATE® Aldolase B (A174D)™</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF190432-B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:24.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598005846</udiDi>
    <basicUdiDi>B-04050598005846</basicUdiDi>
    <tradeName>IDKmonitor® Infliximab total ADA</tradeName>
    <deviceName>IDKmonitor® Infliximab total ADA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9654.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:24.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598005839</udiDi>
    <basicUdiDi>B-04050598005839</basicUdiDi>
    <tradeName>IDKmonitor® Adalimumab total ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab total ADA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9651.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:22.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598005822</udiDi>
    <basicUdiDi>B-04050598005822</basicUdiDi>
    <tradeName>MutaPLATE® GST-M1/T1 (TM)</tradeName>
    <deviceName>MutaPLATE® GST-M1</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF1902196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:21.785Z</lastUpdated>
  </row>
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