<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06925912717836</udiDi>
    <basicUdiDi>692591270071H8</basicUdiDi>
    <tradeName>iFlash-β2-Glycoprotein I IgA</tradeName>
    <deviceName>iFlash-β2-Glycoprotein I IgA</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>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89052A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:24.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912717829</udiDi>
    <basicUdiDi>692591270070H6</basicUdiDi>
    <tradeName>iFlash-Cardiolipin IgA</tradeName>
    <deviceName>iFlash-Cardiolipin IgA</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>W0102100501</emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89040A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:20.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681367</udiDi>
    <basicUdiDi>542502368BDDAPSZQ</basicUdiDi>
    <tradeName>BlueDiverDot APS 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>W0102100599</emdnCode>
    <emdnDescription>ANTI-PHOSPHOLIP SYNDROME - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APSGDIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:41.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680360</udiDi>
    <basicUdiDi>542502368BDAPS2U</basicUdiDi>
    <tradeName>BlueDot APS 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>W0102100599</emdnCode>
    <emdnDescription>ANTI-PHOSPHOLIP SYNDROME - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APSGD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:19.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76449GD</udiDi>
    <basicUdiDi>B-DC76449GD</basicUdiDi>
    <tradeName>iStar-β2-Glycoprotein I IgM</tradeName>
    <deviceName>iStar-β2-Glycoprotein I IgM</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76449</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:58.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-124FE</udiDi>
    <basicUdiDi>B-6-124FE</basicUdiDi>
    <tradeName>D-6-124FE</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 IgA/G/M Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000215M, USIA00000216M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:23.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-123FC</udiDi>
    <basicUdiDi>B-6-123FC</basicUdiDi>
    <tradeName>D-6-123FC</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 IgG Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000211M, USIA00000212M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:22.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-122FA</udiDi>
    <basicUdiDi>B-6-122FA</basicUdiDi>
    <tradeName>D-6-122FA</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 IgA Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000209M, USIA00000210M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:20.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-121F8</udiDi>
    <basicUdiDi>B-6-121F8</basicUdiDi>
    <tradeName>D-6-121F8</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 IgM Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000213M, USIA00000214M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:19.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-120F6</udiDi>
    <basicUdiDi>B-6-120F6</basicUdiDi>
    <tradeName>D-6-120F6</tradeName>
    <deviceName>Anti-Cardiolipin IgA/G/M Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100501</emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000207M, USIA00000208M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:18.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-119FM</udiDi>
    <basicUdiDi>B-6-119FM</basicUdiDi>
    <tradeName>D-6-119FM</tradeName>
    <deviceName>Anti-Cardiolipin IgG Assay Kit(Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100501</emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000203M, USIA00000204M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:15.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-117FH</udiDi>
    <basicUdiDi>B-6-117FH</basicUdiDi>
    <tradeName>D-6-117FH</tradeName>
    <deviceName>Anti-Cardiolipin IgM Assay Kit(Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100501</emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000205M, USIA00000206M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:11.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-118FK</udiDi>
    <basicUdiDi>B-6-118FK</basicUdiDi>
    <tradeName>D-6-118FK</tradeName>
    <deviceName>Anti-Cardiolipin IgA Assay Kit(Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100501</emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000201M, USIA00000202M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:11.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424221833</udiDi>
    <basicUdiDi>B-06975424221833</basicUdiDi>
    <tradeName>Anti-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100504</emdnCode>
    <emdnDescription>APLS SCREENING (OR ANTI-CARDIOLIPIN / ANTI-B2-GLYCOPROTEIN COMBITEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:26:04.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466105417</udiDi>
    <basicUdiDi>B-04099466105417</basicUdiDi>
    <tradeName>04099466105417</tradeName>
    <deviceName>Serazym® Anti-Cardiolipin-ß2-GP-1 IgG/IgM</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:33.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R994496T</udiDi>
    <basicUdiDi>B-R994496T</basicUdiDi>
    <tradeName>D-R994496T</tradeName>
    <deviceName>Anti-Phospholipid Screen IgG/IgM</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>W0102100599</emdnCode>
    <emdnDescription>ANTI-PHOSPHOLIP SYNDROME - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R99449</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:39.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76459GG</udiDi>
    <basicUdiDi>B-DC76459GG</basicUdiDi>
    <tradeName>iStar-Anti-β2-Glycoprotein I</tradeName>
    <deviceName>iStar-Anti-β2-Glycoprotein I</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76459</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:15:38.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76458GE</udiDi>
    <basicUdiDi>B-DC76458GE</basicUdiDi>
    <tradeName>iStar-Anti-β2-Glycoprotein I</tradeName>
    <deviceName>iStar-Anti-β2-Glycoprotein I</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76458</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:15:37.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76457GC</udiDi>
    <basicUdiDi>B-DC76457GC</basicUdiDi>
    <tradeName>iStar-Anti-β2-Glycoprotein I</tradeName>
    <deviceName>iStar-Anti-β2-Glycoprotein I</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76457</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:15:36.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76456GA</udiDi>
    <basicUdiDi>B-DC76456GA</basicUdiDi>
    <tradeName>iStar-Anti-β2-Glycoprotein I</tradeName>
    <deviceName>iStar-Anti-β2-Glycoprotein I</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76456</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:15:35.571Z</lastUpdated>
  </row>
</eudamedExport>