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<eudamedExport entity="devices">
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    <udiDi>04250289503747</udiDi>
    <basicUdiDi>B-04250289503747</basicUdiDi>
    <tradeName>AESKUSLIDES® EMA IgA</tradeName>
    <deviceName>AESKUSLIDES® EMA</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>W0102100603</emdnCode>
    <emdnDescription>ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512.100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:44:13.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289503662</udiDi>
    <basicUdiDi>B-04250289503662</basicUdiDi>
    <tradeName>AESKUSLIDES® EMA IgG</tradeName>
    <deviceName>AESKUSLIDES® EMA</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>W0102100603</emdnCode>
    <emdnDescription>ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512.060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:44:13.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500333</udiDi>
    <basicUdiDi>B-04250289500333</basicUdiDi>
    <tradeName>AESKUSLIDES® EMA IgA</tradeName>
    <deviceName>AESKUSLIDES® EMA</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>W0102100603</emdnCode>
    <emdnDescription>ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512.050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:47.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-anti-tTG706-AEYS</udiDi>
    <basicUdiDi>B-anti-tTG706-AEYS</basicUdiDi>
    <tradeName>Anti-tTG IgG Anti-tissue Transglutaminase IgG Antibody (CLIA)</tradeName>
    <deviceName>Anti-tTG IgG Anti-tissue Transglutaminase IgG Antibody (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"anti-tTG706-AE10Y, anti-tTG706-AE10N, anti-tTG706-AE20Y, anti-tTG706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:04.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01210YQ</udiDi>
    <basicUdiDi>B-R01210YQ</basicUdiDi>
    <tradeName>D-R01210YQ</tradeName>
    <deviceName>Anti-Transglutaminase IgA</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01210</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:15.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76035AV4</udiDi>
    <basicUdiDi>B-DC76035AV4</basicUdiDi>
    <tradeName>iStar-DGP IgA</tradeName>
    <deviceName>iStar-DGP IgA</deviceName>
    <manufacturerName>Hunan Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020269</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76035A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:18.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76034GVD</udiDi>
    <basicUdiDi>B-DC76034GVD</basicUdiDi>
    <tradeName>iStar-DGP IgG</tradeName>
    <deviceName>iStar-DGP IgG</deviceName>
    <manufacturerName>Hunan Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020269</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76034G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:17.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76033AUW</udiDi>
    <basicUdiDi>B-DC76033AUW</basicUdiDi>
    <tradeName>iStar-tTG IgA</tradeName>
    <deviceName>iStar-tTG IgA</deviceName>
    <manufacturerName>Hunan Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020269</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76033A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:16.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313274864</udiDi>
    <basicUdiDi>B-86060313274864</basicUdiDi>
    <tradeName>Anti gliadin Ab</tradeName>
    <deviceName>Anti gliadin Ab</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100604</emdnCode>
    <emdnDescription>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1823GLIA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:51.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313274796</udiDi>
    <basicUdiDi>B-86060313274796</basicUdiDi>
    <tradeName>Anti transglutaminase Ab</tradeName>
    <deviceName>Anti transglutaminase Ab</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1824ATTG</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:50.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147194512</udiDi>
    <basicUdiDi>B-86060147194512</basicUdiDi>
    <tradeName>Anti-Gliadin IgG</tradeName>
    <deviceName>Anti-Gliadin IgG</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100604</emdnCode>
    <emdnDescription>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N245A24GLG</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:07.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147194444</udiDi>
    <basicUdiDi>B-86060147194444</basicUdiDi>
    <tradeName>Anti-Gliadin IgA</tradeName>
    <deviceName>Anti-Gliadin IgA</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100604</emdnCode>
    <emdnDescription>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N244A24GLA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:06.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147194376</udiDi>
    <basicUdiDi>B-86060147194376</basicUdiDi>
    <tradeName>Anti-Gliadin-Check</tradeName>
    <deviceName>Anti-Gliadin-Check</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100604</emdnCode>
    <emdnDescription>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N243A24GLC</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:05.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147194208</udiDi>
    <basicUdiDi>B-86060147194208</basicUdiDi>
    <tradeName>Anti-Tissue-Transglutaminase IgG</tradeName>
    <deviceName>Anti-Tissue-Transglutaminase IgG</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N242A24TTG</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:01.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147194130</udiDi>
    <basicUdiDi>B-86060147194130</basicUdiDi>
    <tradeName>Anti-Tissue-Transglutaminase IgA</tradeName>
    <deviceName>Anti-Tissue-Transglutaminase IgA</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N241A24TTA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:00.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721383</udiDi>
    <basicUdiDi>692591270116H5</basicUdiDi>
    <tradeName>iFlash-DGP IgA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86073A-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721390</udiDi>
    <basicUdiDi>692591270117H7</basicUdiDi>
    <tradeName>iFlash-DGP IgG</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86073G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721406</udiDi>
    <basicUdiDi>692591270118H9</basicUdiDi>
    <tradeName>iFlash-tTG IgA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86072A-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721413</udiDi>
    <basicUdiDi>692591270119HB</basicUdiDi>
    <tradeName>iFlash-tTG IgG</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86072G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-101177LK</udiDi>
    <basicUdiDi>B-101177LK</basicUdiDi>
    <tradeName>Test autodiagnostico Celiachia</tradeName>
    <deviceName>Test autodiagnostico Celiachia</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100604</emdnCode>
    <emdnDescription>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101177-x</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:47:19.495Z</lastUpdated>
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