<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598000483</udiDi>
    <basicUdiDi>B-04050598000483</basicUdiDi>
    <tradeName>IDK® PMN-Elastase ELISA</tradeName>
    <deviceName>IDK® PMN-Elastase ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6841</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:44.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000469</udiDi>
    <basicUdiDi>B-04050598000469</basicUdiDi>
    <tradeName>Lysozym ELISA</tradeName>
    <deviceName>Lysozym ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010124</emdnCode>
    <emdnDescription>LYSOZYME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6903</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:29.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000452</udiDi>
    <basicUdiDi>B-04050598000452</basicUdiDi>
    <tradeName>Lysozym ELISA</tradeName>
    <deviceName>Lysozym ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010124</emdnCode>
    <emdnDescription>LYSOZYME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6902</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:27.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000445</udiDi>
    <basicUdiDi>B-04050598000445</basicUdiDi>
    <tradeName>Lysozym ELISA</tradeName>
    <deviceName>Lysozym ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010124</emdnCode>
    <emdnDescription>LYSOZYME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:26.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000438</udiDi>
    <basicUdiDi>B-04050598000438</basicUdiDi>
    <tradeName>IDK® sIgA (secretory Immunglobulin A) (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® sIgA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 8880</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:25.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000421</udiDi>
    <basicUdiDi>B-04050598000421</basicUdiDi>
    <tradeName>IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7837D.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:22.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000414</udiDi>
    <basicUdiDi>B-04050598000414</basicUdiDi>
    <tradeName>IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7837D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:21.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000407</udiDi>
    <basicUdiDi>B-04050598000407</basicUdiDi>
    <tradeName>IDK® EDN ELISA</tradeName>
    <deviceName>IDK® EDN 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 6821</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:20.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000384</udiDi>
    <basicUdiDi>B-04050598000384</basicUdiDi>
    <tradeName>IDK® α1-Antitrypsin ELISA</tradeName>
    <deviceName>IDK® α1-Antitrypsin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6760</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:18.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000377</udiDi>
    <basicUdiDi>B-04050598000377</basicUdiDi>
    <tradeName>DAO-REA (3H)</tradeName>
    <deviceName>DAO-REA (3H)</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 8220.2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:16.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000353</udiDi>
    <basicUdiDi>B-04050598000353</basicUdiDi>
    <tradeName>CRP (C-reactive Protein) (1-point-calibration) ELISA</tradeName>
    <deviceName>CRP (C-reactive Protein) (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9720s</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:14.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000339</udiDi>
    <basicUdiDi>B-04050598000339</basicUdiDi>
    <tradeName>IDK® Calprotectin ELISA</tradeName>
    <deviceName>IDK® Calprotectin ELISA</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>K 6967</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:14.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000322</udiDi>
    <basicUdiDi>B-04050598000322</basicUdiDi>
    <tradeName>IDK® Biotin (Vitamin H) ELISA</tradeName>
    <deviceName>IDK® Biotin (Vitamin H) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070299</emdnCode>
    <emdnDescription>VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 8141</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:12.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000315</udiDi>
    <basicUdiDi>B-04050598000315</basicUdiDi>
    <tradeName>IDK® Zonulin ELISA</tradeName>
    <deviceName>IDK® Zonulin 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 5601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:10.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000308</udiDi>
    <basicUdiDi>B-04050598000308</basicUdiDi>
    <tradeName>IDK® Kynurenic Acid (KynA) ELISA</tradeName>
    <deviceName>IDK® Kynurenic Acid (KynA) 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 7735</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:08.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000292</udiDi>
    <basicUdiDi>B-04050598000292</basicUdiDi>
    <tradeName>IDK® Helicobacter pylori Antigen ELISA</tradeName>
    <deviceName>IDK® Helicobacter pylori Antigen ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6923</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:07.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000209</udiDi>
    <basicUdiDi>B-04050598000209</basicUdiDi>
    <tradeName>IDKmonitor® Vedolizumab drug level ELISA</tradeName>
    <deviceName>IDKmonitor® Vedolizumab 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>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9658</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:06.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000193</udiDi>
    <basicUdiDi>B-04050598000193</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</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:03.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000179</udiDi>
    <basicUdiDi>B-04050598000179</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</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:02.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000162</udiDi>
    <basicUdiDi>B-04050598000162</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</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:01.329Z</lastUpdated>
  </row>
</eudamedExport>