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<eudamedExport entity="devices">
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    <basicUdiDi>697015090000326HH</basicUdiDi>
    <tradeName>ANA IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ3301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:47:51.948Z</lastUpdated>
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    <udiDi>06925912718895</udiDi>
    <basicUdiDi>692591270039HC</basicUdiDi>
    <tradeName>iFlash-ANA</tradeName>
    <deviceName>iFlash-ANA</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89033G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:32:33.350Z</lastUpdated>
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  <row>
    <udiDi>05425023682005</udiDi>
    <basicUdiDi>542502368BDQANA3C</basicUdiDi>
    <tradeName>BlueDiver Quantrix ANA25 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</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>ANA25Q-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:58.097Z</lastUpdated>
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  <row>
    <udiDi>05425023681305</udiDi>
    <basicUdiDi>542502368BDDANAYE</basicUdiDi>
    <tradeName>BlueDiverDot ANA8 IgG</tradeName>
    <deviceName>BlueDiver Dot ANA Screening</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</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>ANA8DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:37.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680308</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>BlueDot ANA8 IgG</tradeName>
    <deviceName>BlueDot ANA Screening</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</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>ANA8D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:18.557Z</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>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>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>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>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>
  <row>
    <udiDi>04250289500586</udiDi>
    <basicUdiDi>B-04250289500586</basicUdiDi>
    <tradeName>AESKULISA® DANA-Pro</tradeName>
    <deviceName>AESKULISA® DANA-Pro</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>3116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T15:38:01.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500579</udiDi>
    <basicUdiDi>B-04250289500579</basicUdiDi>
    <tradeName>AESKULISA® ANA HEp-2</tradeName>
    <deviceName>AESKULISA® ANA HEp-2</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>3115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T15:38:01.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500432</udiDi>
    <basicUdiDi>B-04250289500432</basicUdiDi>
    <tradeName>AESKULISA® ANA-8Pro</tradeName>
    <deviceName>AESKULISA® ANA-8Pro</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>3101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:53.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500425</udiDi>
    <basicUdiDi>B-04250289500425</basicUdiDi>
    <tradeName>AESKULISA® ANA-8S</tradeName>
    <deviceName>AESKULISA® ANA-8S</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>3100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:53.006Z</lastUpdated>
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    <udiDi>04099466110015</udiDi>
    <basicUdiDi>B-04099466110015</basicUdiDi>
    <tradeName>04099466110015</tradeName>
    <deviceName>Serazym® Nucleo ANA screen plus</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:41.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845533001892</udiDi>
    <basicUdiDi>B-00845533001892</basicUdiDi>
    <tradeName>ANA Hep-2</tradeName>
    <deviceName>ANA Hep-2</deviceName>
    <manufacturerName>ZEUS Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000026845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA2500A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:34:13.734Z</lastUpdated>
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    <udiDi>05425023681695</udiDi>
    <basicUdiDi>542502368BDDANAYE</basicUdiDi>
    <tradeName>BlueDiverDot ANA + DFS-70 IgG</tradeName>
    <deviceName>BlueDiver Dot ANA Screening</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</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>RLH12DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:59:33.485Z</lastUpdated>
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