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<eudamedExport entity="devices">
  <row>
    <udiDi>04049016164036</udiDi>
    <basicUdiDi>4049016EI2771M57</basicUdiDi>
    <tradeName>Anti-Oropouche Virus ELISA (IgM)</tradeName>
    <deviceName>Anti-Oropouche Virus ELISA (IgM)</deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI 2771-9601 M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:17:58.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016164029</udiDi>
    <basicUdiDi>4049016EI2771G4T</basicUdiDi>
    <tradeName>Anti-Oropouche Virus ELISA (IgG)</tradeName>
    <deviceName>Anti-Oropouche Virus ELISA (IgG)</deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI 2771-9601 G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:17:57.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016160311</udiDi>
    <basicUdiDi>4049016FA1522RZ8</basicUdiDi>
    <tradeName>ANA (HEp-20-10) IIFT</tradeName>
    <deviceName>ANA (HEp-20-10) IIFT</deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1522-2005-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:17:54.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016161523</udiDi>
    <basicUdiDi>4049016FA1522RZ8</basicUdiDi>
    <tradeName>ANA (HEp-20-10) IIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1522-1050-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:19.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016161530</udiDi>
    <basicUdiDi>4049016FA1522RZ8</basicUdiDi>
    <tradeName>ANA (HEp-20-10) IIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1522-12010-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:18.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016160328</udiDi>
    <basicUdiDi>4049016FA1522RZ8</basicUdiDi>
    <tradeName>ANA (HEp-20-10) IIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1522-2010-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:10.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016162124</udiDi>
    <basicUdiDi>4049016FA115650RSQ</basicUdiDi>
    <tradeName>Anti-MOG IIFT</tradeName>
    <deviceName>Anti-MOG IIFT</deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1156-2005-50-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:02:43.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016162087</udiDi>
    <basicUdiDi>4049016FA11281RTX</basicUdiDi>
    <tradeName>NMOSD Mosaic 1 IIFT</tradeName>
    <deviceName>NMOSD Mosaic 1 IIFT</deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1128-2005-1-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:02:39.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016160250</udiDi>
    <basicUdiDi>4049016FA1520RZ2</basicUdiDi>
    <tradeName>ANA (HEp-2) IIFT</tradeName>
    <deviceName>ANA (HEp-2) IIFT</deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1520-1050-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:02:39.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016162131</udiDi>
    <basicUdiDi>4049016FA115650RSQ</basicUdiDi>
    <tradeName>Anti-MOG IIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1156-2010-50-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:50:03.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016162094</udiDi>
    <basicUdiDi>4049016FA11281RTX</basicUdiDi>
    <tradeName>NMOSD Mosaic 1 IIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1128-2010-1-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:49:35.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016160267</udiDi>
    <basicUdiDi>4049016FA1520RZ2</basicUdiDi>
    <tradeName>ANA (HEp-2) IIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1520-12010-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:49:25.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016160274</udiDi>
    <basicUdiDi>4049016FA1520RZ2</basicUdiDi>
    <tradeName>ANA (HEp-2) IIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1520-2005-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:49:23.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016160281</udiDi>
    <basicUdiDi>4049016FA1520RZ2</basicUdiDi>
    <tradeName>ANA (HEp-2) IIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1520-2010-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:49:14.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016152064</udiDi>
    <basicUdiDi>4049016ZM9999RN7</basicUdiDi>
    <tradeName>TITERPLANE reagent tray for EUROArray slides</tradeName>
    <deviceName>TITERPLANE reagent tray for EUROArray slides</deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZM 9999-0105-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:42:23.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016151227</udiDi>
    <basicUdiDi>4049016AF101R85</basicUdiDi>
    <tradeName>FITC-labelled anti-human IgA</tradeName>
    <deviceName>FITC-labelled anti-human IgA</deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF 101-0540-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:42:22.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016151593</udiDi>
    <basicUdiDi>4049016AF101R85</basicUdiDi>
    <tradeName>FITC-labelled anti-human IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUROIMMUN Medizinische Labordiagnostika AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005296</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-14T09:21:01.781Z</lastUpdated>
  </row>
</eudamedExport>