<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598008847</udiDi>
    <basicUdiDi>B-04050598008847</basicUdiDi>
    <tradeName>MutaPLATE® GST-P1 (TM)</tradeName>
    <deviceName>MutaPLATE® GST-P1 (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>KF1903196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:54.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008830</udiDi>
    <basicUdiDi>B-04050598008830</basicUdiDi>
    <tradeName>IDK® 25-OH-Vitamin D ELISA</tradeName>
    <deviceName>IDK® 25-OH-Vitamin D ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 2020DBS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:54.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008823</udiDi>
    <basicUdiDi>B-04050598008823</basicUdiDi>
    <tradeName>IDK® anti-SARS-CoV-2 IgG ELISA DBS</tradeName>
    <deviceName>IDK® anti-SARS-CoV-2 IgG ELISA DBS</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>K5004DBS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:53.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008809</udiDi>
    <basicUdiDi>B-04050598008809</basicUdiDi>
    <tradeName>MutaPlex® CoV-2 MUT 3, PCR</tradeName>
    <deviceName>MutaPlex® CoV-2 MUT 3, 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>KG1933-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:52.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008731</udiDi>
    <basicUdiDi>B-04050598008731</basicUdiDi>
    <tradeName>MutaPLATE® Cystic Fibrosis</tradeName>
    <deviceName>MutaPLATE® Cystic Fibrosis</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF190896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:48.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008724</udiDi>
    <basicUdiDi>B-04050598008724</basicUdiDi>
    <tradeName>MutaPLATE® Cystic Fibrosis</tradeName>
    <deviceName>MutaPLATE® Cystic Fibrosis</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF190832</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:47.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008793</udiDi>
    <basicUdiDi>B-04050598008793</basicUdiDi>
    <tradeName>MutaREAL® MTHFR A1298C</tradeName>
    <deviceName>MutaREAL® MTHFR A1298C</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>KF291432-B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:46.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008755</udiDi>
    <basicUdiDi>B-04050598008755</basicUdiDi>
    <tradeName>MutaPLEX MRSA seqc, PCR</tradeName>
    <deviceName>MutaPLEX MRSA seqc, 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>KG194196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:46.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008687</udiDi>
    <basicUdiDi>B-04050598008687</basicUdiDi>
    <tradeName>Homoarginin ELISA</tradeName>
    <deviceName>Homoarginin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7859</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:28.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008656</udiDi>
    <basicUdiDi>B-04050598008656</basicUdiDi>
    <tradeName>Preventis SmarTest® Vitamin D Home</tradeName>
    <deviceName>Preventis SmarTest® Vitamin D Home</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PST80100EP04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:27.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008649</udiDi>
    <basicUdiDi>B-04050598008649</basicUdiDi>
    <tradeName>Preventis SmarTest Pro® Vitamin D</tradeName>
    <deviceName>Preventis SmarTest Pro® Vitamin D</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PST80100GP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:26.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008632</udiDi>
    <basicUdiDi>B-04050598008632</basicUdiDi>
    <tradeName>Preventis SmarTest Pro® Vitamin D</tradeName>
    <deviceName>Preventis SmarTest Pro® Vitamin D</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PST80100G5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:25.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008625</udiDi>
    <basicUdiDi>B-04050598008625</basicUdiDi>
    <tradeName>Preventis SmarTest Pro® Vitamin D</tradeName>
    <deviceName>Preventis SmarTest Pro® Vitamin D</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PST80100TP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:21.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008588</udiDi>
    <basicUdiDi>B-04050598008588</basicUdiDi>
    <tradeName>Nitrotyrosine (EDTA Plasma, Serum, Dried Blood) ELISA</tradeName>
    <deviceName>Nitrotyrosine (EDTA Plasma, Serum, Dried Blood) 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 7829.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:20.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008571</udiDi>
    <basicUdiDi>B-04050598008571</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 6967.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:19.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008533</udiDi>
    <basicUdiDi>B-04050598008533</basicUdiDi>
    <tradeName>MutaPLEX® Bordetella pertussis/parapertussis, PCR</tradeName>
    <deviceName>MutaPLEX® Bordetella pertussis/parapertussis, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:18.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008434</udiDi>
    <basicUdiDi>B-04050598008434</basicUdiDi>
    <tradeName>MutaREAL DPD-2, PCR</tradeName>
    <deviceName>MutaREAL DPD-2, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF292096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:14.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008427</udiDi>
    <basicUdiDi>B-04050598008427</basicUdiDi>
    <tradeName>MutaREAL DPD-2, PCR</tradeName>
    <deviceName>MutaREAL DPD-2, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF292032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:13.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008335</udiDi>
    <basicUdiDi>B-04050598008335</basicUdiDi>
    <tradeName>MutaPlex Borrelia/Rickettsia, PCR</tradeName>
    <deviceName>MutaPlex Borrelia/Rickettsia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG194096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:13.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008328</udiDi>
    <basicUdiDi>B-04050598008328</basicUdiDi>
    <tradeName>MutaPlex Borrelia/Rickettsia, PCR</tradeName>
    <deviceName>MutaPlex Borrelia/Rickettsia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG194032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:12.388Z</lastUpdated>
  </row>
</eudamedExport>