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<eudamedExport entity="devices">
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    <udiDi>04987506018417</udiDi>
    <basicUdiDi>498750601841KA</basicUdiDi>
    <tradeName>Anti-Integrin αvβ6 ELISA Kit (IVD)</tradeName>
    <deviceName>Anti-Integrin αvβ6 ELISA Kit (IVD)</deviceName>
    <manufacturerName>MEDICAL &amp; BIOLOGICAL LABORATORIES CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000017864</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>7670E</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:45.276Z</lastUpdated>
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  <row>
    <udiDi>04987506016833</udiDi>
    <basicUdiDi>498750601683KG</basicUdiDi>
    <tradeName>04987506016833</tradeName>
    <deviceName>MESACUP-2 TEST Desmoglein 3</deviceName>
    <manufacturerName>MEDICAL &amp; BIOLOGICAL LABORATORIES CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000017864</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>7886E</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:38.866Z</lastUpdated>
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  <row>
    <udiDi>04987506016826</udiDi>
    <basicUdiDi>498750601682KE</basicUdiDi>
    <tradeName>04987506016826</tradeName>
    <deviceName>MESACUP-2 TEST Desmoglein 1</deviceName>
    <manufacturerName>MEDICAL &amp; BIOLOGICAL LABORATORIES CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000017864</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>7881E</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:38.069Z</lastUpdated>
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  <row>
    <udiDi>04987506016819</udiDi>
    <basicUdiDi>498750601681KC</basicUdiDi>
    <tradeName>04987506016819</tradeName>
    <deviceName>MESACUP BP180 TEST</deviceName>
    <manufacturerName>MEDICAL &amp; BIOLOGICAL LABORATORIES CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000017864</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>7697E</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:37.266Z</lastUpdated>
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  <row>
    <udiDi>04987506016802</udiDi>
    <basicUdiDi>498750601680KA</basicUdiDi>
    <tradeName>04987506016802</tradeName>
    <deviceName>MESACUP BP230 TEST</deviceName>
    <manufacturerName>MEDICAL &amp; BIOLOGICAL LABORATORIES CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000017864</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>7614E</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:33.263Z</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>
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  <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>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>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>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>D-A036D4</udiDi>
    <basicUdiDi>B-A036D4</basicUdiDi>
    <tradeName>INDICAID™ Anti-ovarian Antibody Test</tradeName>
    <deviceName>INDICAID™ Anti-ovarian Antibody Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Anti-ovarian Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T15:17:46.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771200882</udiDi>
    <basicUdiDi>B-08056771200882</basicUdiDi>
    <tradeName>LIAISON® tTG IgA</tradeName>
    <deviceName>LIAISON® tTG IgA</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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310320</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:40:22.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A5093</udiDi>
    <basicUdiDi>B-A5093</basicUdiDi>
    <tradeName>D-A5093</tradeName>
    <deviceName>INDICAID™ Antisperm Antibody Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Antisperm Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:47.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757990302PS</udiDi>
    <basicUdiDi>B-693757990302PS</basicUdiDi>
    <tradeName>Fast Diagnostic Screening Test for Sperm Concentration</tradeName>
    <deviceName>Fast Diagnostic Screening Test for Sperm Concentration</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZMD cassette</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:41.104Z</lastUpdated>
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  <row>
    <udiDi>D-6-116FF</udiDi>
    <basicUdiDi>B-6-116FF</basicUdiDi>
    <tradeName>D-6-116FF</tradeName>
    <deviceName>Anti-Trophoblast cell membrane antibody 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000199M, USIA00000200M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:11.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-115FD</udiDi>
    <basicUdiDi>B-6-115FD</basicUdiDi>
    <tradeName>D-6-115FD</tradeName>
    <deviceName>Anti-Human chorionic gonadotropin Antibody 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000197M, USIA00000198M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:07.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-114FB</udiDi>
    <basicUdiDi>B-6-114FB</basicUdiDi>
    <tradeName>D-6-114FB</tradeName>
    <deviceName>Anti-Zona Pellucida 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000195M, USIA00000196M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:05.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-113F9</udiDi>
    <basicUdiDi>B-6-113F9</basicUdiDi>
    <tradeName>D-6-113F9</tradeName>
    <deviceName>Anti-Zona Pellucida 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000193M, USIA00000194M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:04.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-110F3</udiDi>
    <basicUdiDi>B-6-110F3</basicUdiDi>
    <tradeName>D-6-110F3</tradeName>
    <deviceName>Anti-Ovarian 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000187M, USIA00000188M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:58.716Z</lastUpdated>
  </row>
</eudamedExport>