<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598002548</udiDi>
    <basicUdiDi>B-04050598002548</basicUdiDi>
    <tradeName>MutaPLEX® FSME, PCR</tradeName>
    <deviceName>MutaPLEX® FSME, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1916096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:46.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002500</udiDi>
    <basicUdiDi>B-04050598002500</basicUdiDi>
    <tradeName>MutaPLEX® Norovirus, PCR</tradeName>
    <deviceName>MutaPLEX® Norovirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040516</emdnCode>
    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:31.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002494</udiDi>
    <basicUdiDi>B-04050598002494</basicUdiDi>
    <tradeName>MutaPLEX® MRSA, PCR</tradeName>
    <deviceName>MutaPLEX® MRSA, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080602</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190396</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:29.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002470</udiDi>
    <basicUdiDi>B-04050598002470</basicUdiDi>
    <tradeName>MutaPLEX® Legionella spp., PCR</tradeName>
    <deviceName>MutaPLEX® Legionella spp., PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010503</emdnCode>
    <emdnDescription>LEGIONELLA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG191996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:28.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002463</udiDi>
    <basicUdiDi>B-04050598002463</basicUdiDi>
    <tradeName>MutaPLEX® Legionella pneumophila, PCR</tradeName>
    <deviceName>MutaPLEX® Legionella pneumophila, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010503</emdnCode>
    <emdnDescription>LEGIONELLA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG196496</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:27.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002456</udiDi>
    <basicUdiDi>B-04050598002456</basicUdiDi>
    <tradeName>MutaPLEX® GastroSys 3 (Multiplex-Panel), RT-PCR</tradeName>
    <deviceName>MutaPLEX® GastroSys 3 (Multiplex-Panel), RT-PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG198896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:24.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002432</udiDi>
    <basicUdiDi>B-04050598002432</basicUdiDi>
    <tradeName>MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR</tradeName>
    <deviceName>MutaPLEX® GastroSys1 Mulitplex-Test: Adenovirus, Norovirus (GI &amp; II), Rotavirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG198696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:23.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002425</udiDi>
    <basicUdiDi>B-04050598002425</basicUdiDi>
    <tradeName>MutaPLEX® Borrelia, PCR</tradeName>
    <deviceName>MutaPLEX® Borrelia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010605</emdnCode>
    <emdnDescription>LYME DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1917096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:22.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002418</udiDi>
    <basicUdiDi>B-04050598002418</basicUdiDi>
    <tradeName>MutaPLEX® Enterovirus, PCR</tradeName>
    <deviceName>MutaPLEX® Enterovirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:20.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002395</udiDi>
    <basicUdiDi>B-04050598002395</basicUdiDi>
    <tradeName>MutaPLATE® MTHFR™</tradeName>
    <deviceName>MutaPLATE® MTHFR™</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>KF1901496</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:18.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002371</udiDi>
    <basicUdiDi>B-04050598002371</basicUdiDi>
    <tradeName>MutaPLATE® HLA-DQ 2+8 (TM)</tradeName>
    <deviceName>MutaPLATE® HLA-DQ 2+8 (TM)</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>KF190596</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:16.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002364</udiDi>
    <basicUdiDi>B-04050598002364</basicUdiDi>
    <tradeName>MutaPLATE® Faktor V</tradeName>
    <deviceName>MutaPLATE® Faktor V</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF1901796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:15.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002357</udiDi>
    <basicUdiDi>B-04050598002357</basicUdiDi>
    <tradeName>MutaPLATE® Faktor II</tradeName>
    <deviceName>MutaPLATE® Faktor II</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010114</emdnCode>
    <emdnDescription>PROTHROMBIN MUTATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF1901696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:14.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002302</udiDi>
    <basicUdiDi>B-04050598002302</basicUdiDi>
    <tradeName>IDKmonitor® Ustekinumab drug level ELISA</tradeName>
    <deviceName>IDKmonitor® Ustekinumab 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 9660</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:11.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002272</udiDi>
    <basicUdiDi>B-04050598002272</basicUdiDi>
    <tradeName>MutaPLEX® GBS (Group B Streptococci), PCR</tradeName>
    <deviceName>MutaPLEX® GBS (Group B Streptococci), PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG191096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:10.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002258</udiDi>
    <basicUdiDi>B-04050598002258</basicUdiDi>
    <tradeName>MutaPLATE® VDR BsmI Real-Time-PCR-Kit</tradeName>
    <deviceName>MutaPLATE® VDR BsmI Real-Time-PCR-Kit</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>KF1900496</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:09.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002241</udiDi>
    <basicUdiDi>B-04050598002241</basicUdiDi>
    <tradeName>MutaPLATE® VDR BsmI Real-Time-PCR-Kit</tradeName>
    <deviceName>MutaPLATE® VDR3/Bsm1 ™, PCR</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>KF1900432</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:07.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002234</udiDi>
    <basicUdiDi>B-04050598002234</basicUdiDi>
    <tradeName>MutaPLEX® Tropica 1, PCR</tradeName>
    <deviceName>MutaPLEX® Tropica 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG199096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:05.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002180</udiDi>
    <basicUdiDi>B-04050598002180</basicUdiDi>
    <tradeName>MutaREAL® ApoE</tradeName>
    <deviceName>MutaREAL® ApoE</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>KF290732</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:03.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002173</udiDi>
    <basicUdiDi>B-04050598002173</basicUdiDi>
    <tradeName>MutaREAL® ApoE</tradeName>
    <deviceName>MutaREAL® ApoE</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>KF290796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:03.091Z</lastUpdated>
  </row>
</eudamedExport>