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<eudamedExport entity="devices">
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    <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>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>04260158680103</udiDi>
    <basicUdiDi>B-04260158680103</basicUdiDi>
    <tradeName>SS-B</tradeName>
    <deviceName>SS-B</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:19.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680073</udiDi>
    <basicUdiDi>B-04260158680073</basicUdiDi>
    <tradeName>SS-A</tradeName>
    <deviceName>SS-A</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:15.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680066</udiDi>
    <basicUdiDi>B-04260158680066</basicUdiDi>
    <tradeName>Sm</tradeName>
    <deviceName>Sm</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100111</emdnCode>
    <emdnDescription>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:14.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680059</udiDi>
    <basicUdiDi>B-04260158680059</basicUdiDi>
    <tradeName>RNP complex</tradeName>
    <deviceName>RNP complex</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:13.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680042</udiDi>
    <basicUdiDi>B-04260158680042</basicUdiDi>
    <tradeName>U1-70</tradeName>
    <deviceName>U1-70</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:12.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680035</udiDi>
    <basicUdiDi>B-04260158680035</basicUdiDi>
    <tradeName>ENA Profile</tradeName>
    <deviceName>ENA Profile</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:08.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680028</udiDi>
    <basicUdiDi>B-04260158680028</basicUdiDi>
    <tradeName>ENA Screen</tradeName>
    <deviceName>ENA Screen</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:07.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680011</udiDi>
    <basicUdiDi>B-04260158680011</basicUdiDi>
    <tradeName>ANA Profile</tradeName>
    <deviceName>ANA Profile</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:07.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680004</udiDi>
    <basicUdiDi>B-04260158680004</basicUdiDi>
    <tradeName>ANA Screen</tradeName>
    <deviceName>ANA Screen</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:06.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500678</udiDi>
    <basicUdiDi>B-04250289500678</basicUdiDi>
    <tradeName>AESKULISA® ssDNA-A</tradeName>
    <deviceName>AESKULISA® ssDNA-A s</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100106</emdnCode>
    <emdnDescription>SS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3145</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:03:27.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500661</udiDi>
    <basicUdiDi>B-04250289500661</basicUdiDi>
    <tradeName>AESKULISA® ssDNA-Check</tradeName>
    <deviceName>AESKULISA® ssDNA-Check</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100106</emdnCode>
    <emdnDescription>SS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3144</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:03:26.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500654</udiDi>
    <basicUdiDi>B-04250289500654</basicUdiDi>
    <tradeName>AESKULISA® dsDNA-M</tradeName>
    <deviceName>AESKULISA® dsDNA-M</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3143</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:03:22.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500647</udiDi>
    <basicUdiDi>B-04250289500647</basicUdiDi>
    <tradeName>AESKULISA® dsDNA-G</tradeName>
    <deviceName>AESKULISA® dsDNA-G</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:03:21.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OANA-402D7</udiDi>
    <basicUdiDi>B-OANA-402D7</basicUdiDi>
    <tradeName>Antinuclear Antibody (ANA) Rapid Test</tradeName>
    <deviceName>Antinuclear Antibody (ANA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OANA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:30:02.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289503495</udiDi>
    <basicUdiDi>B-04250289503495</basicUdiDi>
    <tradeName>AESKULISA® ENA-6 Stripes</tradeName>
    <deviceName>AESKULISA® ENA-6 Stripes</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T15:38:06.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289503426</udiDi>
    <basicUdiDi>B-04250289503426</basicUdiDi>
    <tradeName>AESKULISA® ANA Hep-2 quantitative</tradeName>
    <deviceName>AESKULISA® ANA Hep-2 quantitative</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3119</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T15:38:03.457Z</lastUpdated>
  </row>
</eudamedExport>