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<eudamedExport entity="devices">
  <row>
    <udiDi>04050598000155</udiDi>
    <basicUdiDi>B-04050598000155</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</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:59.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000100</udiDi>
    <basicUdiDi>B-04050598000100</basicUdiDi>
    <tradeName>MutaPLEX® EU/BAC/BIF, PCR</tradeName>
    <deviceName>MutaPLEX® EU/BAC/BIF, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080699</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1912-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:57.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000094</udiDi>
    <basicUdiDi>B-04050598000094</basicUdiDi>
    <tradeName>MutaPLEX® AKM/FAEP, PCR</tradeName>
    <deviceName>MutaPLEX® AKM/FAEP, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080699</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1911-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:55.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000063</udiDi>
    <basicUdiDi>B-04050598000063</basicUdiDi>
    <tradeName>IDK® Bile Acids (Serum), photometric</tradeName>
    <deviceName>IDK® Bile Acids (Serum), photometric</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7877W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:54.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000049</udiDi>
    <basicUdiDi>B-04050598000049</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 7012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:53.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000032</udiDi>
    <basicUdiDi>B-04050598000032</basicUdiDi>
    <tradeName>IDK® Bile Acids</tradeName>
    <deviceName>IDK® Bile Acids</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7878W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:50.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000001</udiDi>
    <basicUdiDi>B-04050598000001</basicUdiDi>
    <tradeName>MutaPLEX® AKM/FAEP, PCR</tradeName>
    <deviceName>MutaPLEX® AKM/FAEP, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080699</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1911-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:46.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598015968</udiDi>
    <basicUdiDi>4050598DVAuto5H</basicUdiDi>
    <tradeName>IDK TREx®</tradeName>
    <deviceName>IDK TREx®</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6993</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:32.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598014619</udiDi>
    <basicUdiDi>4050598MNTRELXY</basicUdiDi>
    <tradeName>selenOtest ELISA</tradeName>
    <deviceName>selenOtest ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YC5900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:30.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598013971</udiDi>
    <basicUdiDi>4050598IALCIntolPY</basicUdiDi>
    <tradeName>IDK® DAO ELISA</tradeName>
    <deviceName>IDK® DAO ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y8500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:29.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598013803</udiDi>
    <basicUdiDi>4050598LCACPhysiolLL</basicUdiDi>
    <tradeName>UPLC column</tradeName>
    <deviceName>Accessories for Pregnolone sulfate LC-MS/MS</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM2000SP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:28.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598013636</udiDi>
    <basicUdiDi>4050598DVOmicMetaJ4</basicUdiDi>
    <tradeName>OmicSnap® Meta</tradeName>
    <deviceName>OmicSnap® Meta</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KV10022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:25.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598012707</udiDi>
    <basicUdiDi>4050598DVPhysiolW8</basicUdiDi>
    <tradeName>Pregnenolone sulfate LC-MS/MS</tradeName>
    <deviceName>Pregnenolone sulfate LC-MS/MS</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069099</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM2000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:24.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598012462</udiDi>
    <basicUdiDi>4050598IAInflamM5</basicUdiDi>
    <tradeName>IDK® TNFα ELISA</tradeName>
    <deviceName>IDK® TNFα ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030603</emdnCode>
    <emdnDescription>TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y9610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:23.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598012325</udiDi>
    <basicUdiDi>4050598CMVITV2</basicUdiDi>
    <tradeName>1,25-(OH)2-Vitamin D3/D2 IDKenhance® ImmuPlate® DIY LC-MS/MS</tradeName>
    <deviceName>1,25-(OH)2-Vitamin D3/D2 ImmuTube® LC-MS/MS</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060308</emdnCode>
    <emdnDescription>1.25-DIHYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM1022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:21.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598011991</udiDi>
    <basicUdiDi>4050598LCACVITQV</basicUdiDi>
    <tradeName>Tuning solution for the analyte</tradeName>
    <deviceName>Accessories for 1,25-(OH)2-Vitamin D3/D2 LC-MS/MS product variants</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM1000TU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:19.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598011946</udiDi>
    <basicUdiDi>4050598LCACFELX</basicUdiDi>
    <tradeName>Tuning solution for the analyte</tradeName>
    <deviceName>Accessories for Hepcidin-25 LC-MS/MS</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM4000TU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:17.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598011830</udiDi>
    <basicUdiDi>4050598IAhighXE2</basicUdiDi>
    <tradeName>IDKhighX® stool preparation system – empty</tradeName>
    <deviceName>IDKhighX® stool preparation system</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6997X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:17.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598011823</udiDi>
    <basicUdiDi>4050598DVUrineSetVZ</basicUdiDi>
    <tradeName>SendNTest® Urine</tradeName>
    <deviceName>SendNTest® Urine</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010299</emdnCode>
    <emdnDescription>URINE COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST99990GS02.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:15.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598011045</udiDi>
    <basicUdiDi>4050598DVOmicSnapKY</basicUdiDi>
    <tradeName>OmicSnap Tube</tradeName>
    <deviceName>OmicSnap Tube</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KV10021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:13.105Z</lastUpdated>
  </row>
</eudamedExport>