<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76032GV7</udiDi>
    <basicUdiDi>B-DC76032GV7</basicUdiDi>
    <tradeName>iStar-tTG IgG</tradeName>
    <deviceName>iStar-tTG IgG</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>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76032G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:08:58.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016162124</udiDi>
    <basicUdiDi>4049016FA115650RSQ</basicUdiDi>
    <tradeName>Anti-MOG IIFT</tradeName>
    <deviceName>Anti-MOG 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1156-2005-50-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:02:43.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016162087</udiDi>
    <basicUdiDi>4049016FA11281RTX</basicUdiDi>
    <tradeName>NMOSD Mosaic 1 IIFT</tradeName>
    <deviceName>NMOSD Mosaic 1 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1128-2005-1-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:02:39.891Z</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>04049016162131</udiDi>
    <basicUdiDi>4049016FA115650RSQ</basicUdiDi>
    <tradeName>Anti-MOG 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1156-2010-50-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:50:03.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049016162094</udiDi>
    <basicUdiDi>4049016FA11281RTX</basicUdiDi>
    <tradeName>NMOSD Mosaic 1 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA 1128-2010-1-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:49:35.646Z</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>86060147157500</udiDi>
    <basicUdiDi>B-86060147157500</basicUdiDi>
    <tradeName>Anti-GBM</tradeName>
    <deviceName>Anti-GBM</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>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N264A24GBM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:58.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147157050</udiDi>
    <basicUdiDi>B-86060147157050</basicUdiDi>
    <tradeName>Anti-PR3 hs</tradeName>
    <deviceName>Anti-PR3 hs</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>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N262A24PR3</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:56.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147156688</udiDi>
    <basicUdiDi>B-86060147156688</basicUdiDi>
    <tradeName>Anti Insulin</tradeName>
    <deviceName>Anti Insulin</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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N281A24INS</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:55.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147156510</udiDi>
    <basicUdiDi>B-86060147156510</basicUdiDi>
    <tradeName>Anti-MPO</tradeName>
    <deviceName>Anti-MPO</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>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N263A24MPO</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:53.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147154776</udiDi>
    <basicUdiDi>B-86060147154776</basicUdiDi>
    <tradeName>ANCA-Pro</tradeName>
    <deviceName>ANCA-Pro</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>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N261A24ACA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:51.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771200301</udiDi>
    <basicUdiDi>B-08056771200301</basicUdiDi>
    <tradeName>LIAISON® Anti-TPO</tradeName>
    <deviceName>LIAISON® Anti-TPO</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:28.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GGTTG-402aOGJP</udiDi>
    <basicUdiDi>B-GGTTG-402aOGJP</basicUdiDi>
    <tradeName>Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGTTG-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:47.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GGTTG-402aHGJ2</udiDi>
    <basicUdiDi>B-GGTTG-402aHGJ2</basicUdiDi>
    <tradeName>Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGTTG-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:46.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852395</udiDi>
    <basicUdiDi>B-06933289852395</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroid Peroxidase (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA47P0006</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:22.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852364</udiDi>
    <basicUdiDi>B-06933289852364</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroid Peroxidase (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA47P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:18.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852357</udiDi>
    <basicUdiDi>B-06933289852357</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroglobulin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA48P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:18.114Z</lastUpdated>
  </row>
</eudamedExport>