<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76319FX</udiDi>
    <basicUdiDi>B-DC76319FX</basicUdiDi>
    <tradeName>iStar-Anti-TPO</tradeName>
    <deviceName>iStar-Anti-TPO</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>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76319</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:17.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76318FV</udiDi>
    <basicUdiDi>B-DC76318FV</basicUdiDi>
    <tradeName>iStar-Anti-TPO</tradeName>
    <deviceName>iStar-Anti-TPO</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>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76318</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:16.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76062FH</udiDi>
    <basicUdiDi>B-DC76062FH</basicUdiDi>
    <tradeName>iStar-dsDNA IgG</tradeName>
    <deviceName>iStar-dsDNA IgG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:45.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76061FF</udiDi>
    <basicUdiDi>B-DC76061FF</basicUdiDi>
    <tradeName>iStar-ANA</tradeName>
    <deviceName>iStar-ANA</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76061</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:44.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76058FS</udiDi>
    <basicUdiDi>B-DC76058FS</basicUdiDi>
    <tradeName>iStar-Anti-TSHR</tradeName>
    <deviceName>iStar-Anti-TSHR</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76058</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:39.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76055FL</udiDi>
    <basicUdiDi>B-DC76055FL</basicUdiDi>
    <tradeName>iStar-Anti-Tg</tradeName>
    <deviceName>iStar-Anti-Tg</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76055</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:35.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76054FJ</udiDi>
    <basicUdiDi>B-DC76054FJ</basicUdiDi>
    <tradeName>iStar-Anti-TPO</tradeName>
    <deviceName>iStar-Anti-TPO</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76054</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:32.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76037FJ</udiDi>
    <basicUdiDi>B-DC76037FJ</basicUdiDi>
    <tradeName>iStar-CHI3L1</tradeName>
    <deviceName>iStar-CHI3L1</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>W0102100799</emdnCode>
    <emdnDescription>AUTOIMMUNE HEPATITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76037</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:22.464Z</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>D-DC76017FC</udiDi>
    <basicUdiDi>B-DC76017FC</basicUdiDi>
    <tradeName>iStar-Anti-Tg</tradeName>
    <deviceName>iStar-Anti-Tg</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>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:44.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76016FA</udiDi>
    <basicUdiDi>B-DC76016FA</basicUdiDi>
    <tradeName>iStar-Anti-TPO</tradeName>
    <deviceName>iStar-Anti-TPO</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>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76016</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:43.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2486-100M96</udiDi>
    <basicUdiDi>B-CK-2486-100M96</basicUdiDi>
    <tradeName>D-CK-2486-100M96</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-100M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:36.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2486-100G8S</udiDi>
    <basicUdiDi>B-CK-2486-100G8S</basicUdiDi>
    <tradeName>D-CK-2486-100G8S</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-100G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:36.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2486-100A8E</udiDi>
    <basicUdiDi>B-CK-2486-100A8E</basicUdiDi>
    <tradeName>D-CK-2486-100A8E</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-100A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:34.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2486-050M9Q</udiDi>
    <basicUdiDi>B-CK-2486-050M9Q</basicUdiDi>
    <tradeName>D-CK-2486-050M9Q</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-050M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:31.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2486-050G9C</udiDi>
    <basicUdiDi>B-CK-2486-050G9C</basicUdiDi>
    <tradeName>D-CK-2486-050G9C</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-050G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:29.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2486-050A8Y</udiDi>
    <basicUdiDi>B-CK-2486-050A8Y</basicUdiDi>
    <tradeName>D-CK-2486-050A8Y</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-050A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:29.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2485-100M8R</udiDi>
    <basicUdiDi>B-CK-2485-100M8R</basicUdiDi>
    <tradeName>D-CK-2485-100M8R</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-100M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:26.993Z</lastUpdated>
  </row>
</eudamedExport>