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<eudamedExport entity="devices">
  <row>
    <udiDi>04050598003866</udiDi>
    <basicUdiDi>B-04050598003866</basicUdiDi>
    <tradeName>IDKmonitor® Ustekinumab free ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Ustekinumab free ADA 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 9666</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:24.882Z</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>04050598000957</udiDi>
    <basicUdiDi>B-04050598000957</basicUdiDi>
    <tradeName>IDKmonitor® Vedolizumab free ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Vedolizumab free ADA 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 9648</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:12.625Z</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>
  <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>03532678603551</udiDi>
    <basicUdiDi>B-03532678603551</basicUdiDi>
    <tradeName>Procise IFX Assay</tradeName>
    <deviceName>Procise IFX Assay</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4828_</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:47:59.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532678603520</udiDi>
    <basicUdiDi>B-03532678603520</basicUdiDi>
    <tradeName>Procise ADL Assay</tradeName>
    <deviceName>Procise ADL Assay</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4853_</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:47:53.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000875</udiDi>
    <basicUdiDi>B-03532672000875</basicUdiDi>
    <tradeName>LISA-TRACKER Anti-Secukinumab</tradeName>
    <deviceName>LISA-TRACKER Anti-Secukinumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTS 003-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:52.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000868</udiDi>
    <basicUdiDi>B-03532672000868</basicUdiDi>
    <tradeName>LISA-TRACKER Secukinumab</tradeName>
    <deviceName>LISA-TRACKER Secukinumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTS 002-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:51.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000851</udiDi>
    <basicUdiDi>B-03532672000851</basicUdiDi>
    <tradeName>LISA-TRACKER Duo-Vedolizumab</tradeName>
    <deviceName>LISA-TRACKER Duo-Vedolizumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTV 005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:50.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000844</udiDi>
    <basicUdiDi>B-03532672000844</basicUdiDi>
    <tradeName>LISA-TRACKER Anti-Vedolizumab</tradeName>
    <deviceName>LISA-TRACKER Anti-Vedolizumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTV 003-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:50.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000813</udiDi>
    <basicUdiDi>B-03532672000813</basicUdiDi>
    <tradeName>LISA-TRACKER Anti-Ustekinumab</tradeName>
    <deviceName>LISA-TRACKER Anti-Ustekinumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTU 003-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:46.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000837</udiDi>
    <basicUdiDi>B-03532672000837</basicUdiDi>
    <tradeName>LISA-TRACKER Vedolizumab</tradeName>
    <deviceName>LISA-TRACKER Vedolizumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTV 002-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:45.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000820</udiDi>
    <basicUdiDi>B-03532672000820</basicUdiDi>
    <tradeName>LISA-TRACKER Duo-Ustekinumab</tradeName>
    <deviceName>LISA-TRACKER Duo-Ustekinumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTU 005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:44.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000806</udiDi>
    <basicUdiDi>B-03532672000806</basicUdiDi>
    <tradeName>LISA-TRACKER Ustekinumab</tradeName>
    <deviceName>LISA-TRACKER Ustekinumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTU 002-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:43.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000790</udiDi>
    <basicUdiDi>B-03532672000790</basicUdiDi>
    <tradeName>LISA-TRACKER Anti-Trastuzumab</tradeName>
    <deviceName>LISA-TRACKER Anti-Trastuzumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTTR 003-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:27.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000783</udiDi>
    <basicUdiDi>B-03532672000783</basicUdiDi>
    <tradeName>LISA-TRACKER Trastuzumab</tradeName>
    <deviceName>LISA-TRACKER Trastuzumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>LTTR 002-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:26.862Z</lastUpdated>
  </row>
</eudamedExport>