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    <basicUdiDi>542502368BDGASTRITISLY</basicUdiDi>
    <tradeName>BlueDot Gastritis 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFPCAD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:24.481Z</lastUpdated>
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  <row>
    <udiDi>05425023680421</udiDi>
    <basicUdiDi>542502368BDCELIACE4</basicUdiDi>
    <tradeName>BlueDot Celiac IgA</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>W0102100602</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDA-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:23.683Z</lastUpdated>
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    <udiDi>05425023680407</udiDi>
    <basicUdiDi>542502368BDCYTOPLASMUE</basicUdiDi>
    <tradeName>BlueDot Cytoplasm6 IgG</tradeName>
    <deviceName>BlueDot Cytoplasm</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>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY6D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:22.080Z</lastUpdated>
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    <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>
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    <udiDi>05425023680308</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>BlueDot ANA8 IgG</tradeName>
    <deviceName>BlueDot ANA Screening</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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANA8D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:18.557Z</lastUpdated>
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  <row>
    <udiDi>05425023680353</udiDi>
    <basicUdiDi>542502368BDANCAYR</basicUdiDi>
    <tradeName>BlueDot ANCA+GBM 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>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANCAGD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:18.534Z</lastUpdated>
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  <row>
    <udiDi>05411967002542</udiDi>
    <basicUdiDi>5411967SPMGS135</basicUdiDi>
    <tradeName>SpermMar Test IgG antiserum</tradeName>
    <deviceName>SpermMar Test IgG Single kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMG_A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:59:56.934Z</lastUpdated>
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    <udiDi>05411967002566</udiDi>
    <basicUdiDi>5411967SPMAS127</basicUdiDi>
    <tradeName>SpermMar Test IgA Single kit</tradeName>
    <deviceName>SpermMar Test IgA Single kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMA_S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:52:04.737Z</lastUpdated>
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    <udiDi>05411967001354</udiDi>
    <basicUdiDi>5411967SPMGC1ZJ</basicUdiDi>
    <tradeName>SpermMar Test IgG Complete kit</tradeName>
    <deviceName>SpermMar Test IgG Complete kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMG_C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:51:56.735Z</lastUpdated>
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    <udiDi>05411967001347</udiDi>
    <basicUdiDi>5411967SPMAC1YL</basicUdiDi>
    <tradeName>SpermMar Test IgA Complete kit</tradeName>
    <deviceName>SpermMar Test IgA Complete kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMA_C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:51:56.059Z</lastUpdated>
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    <udiDi>05411967000036</udiDi>
    <basicUdiDi>5411967SPMGS135</basicUdiDi>
    <tradeName>SpermMar Test IgG Single kit</tradeName>
    <deviceName>SpermMar Test IgG Single kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMG_S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:51:37.909Z</lastUpdated>
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    <udiDi>04987506018448</udiDi>
    <basicUdiDi>498750601844KG</basicUdiDi>
    <tradeName>MESACUP TypeVII Collagen TEST</tradeName>
    <deviceName>MESACUP TypeVII Collagen 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>7846E</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:46.073Z</lastUpdated>
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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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    <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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    <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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    <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>
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    <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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    <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>
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    <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>
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    <udiDi>04260157632172</udiDi>
    <basicUdiDi>426015763852BantTPOnKXX2Q</basicUdiDi>
    <tradeName>B·R·A·H·M·S anti-TPOn KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S anti-TPOn KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:21.668Z</lastUpdated>
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    <tradeName>B·R·A·H·M·S anti-Tgn KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S anti-Tgn KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>830075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:13.668Z</lastUpdated>
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    <udiDi>04260157631823</udiDi>
    <basicUdiDi>426015763801BTRAKhumKXXMX</basicUdiDi>
    <tradeName>B·R·A·H·M·S TRAK human KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S TRAK human KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801050N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:48.053Z</lastUpdated>
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