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    <manufacturerName>OPERON, S.A.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-12T07:08:29.337Z</lastUpdated>
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    <basicUdiDi>B-84295773135WPG2</basicUdiDi>
    <tradeName>LactoStrip</tradeName>
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    <manufacturerName>OPERON, S.A.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0106010402</emdnCode>
    <emdnDescription>LACTOSE INTOLERANCE (POLYMORPHISMS)</emdnDescription>
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    <reference>3.135.XXX.YY.ZZZ</reference>
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    <lastUpdated>2026-07-12T07:08:20.530Z</lastUpdated>
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    <udiDi>09120110506405</udiDi>
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    <tradeName>FetoGnost® Kit RHD</tradeName>
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    <manufacturerName>Ingenetix GmbH</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceName>AlloSeq HCT</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASHCT.1(96)-IVD</reference>
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    <lastUpdated>2026-07-11T11:12:05.662Z</lastUpdated>
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    <basicUdiDi>B-19358706000083</basicUdiDi>
    <tradeName>19358706000083</tradeName>
    <deviceName>AlloSeq cfDNA</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000046711</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASCF.1(24)-IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:12:03.916Z</lastUpdated>
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    <udiDi>16975843690088</udiDi>
    <basicUdiDi>B-16975843690088</basicUdiDi>
    <tradeName>16975843690088</tradeName>
    <deviceName>High Myopia Risk Prediction Gene Test Kit (Gene sequencing)</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:09:57.810Z</lastUpdated>
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    <udiDi>16975843690071</udiDi>
    <basicUdiDi>B-16975843690071</basicUdiDi>
    <tradeName>16975843690071</tradeName>
    <deviceName>High Myopia Risk Prediction Gene Test Kit (Gene sequencing)</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:09:53.786Z</lastUpdated>
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    <udiDi>08908020139507</udiDi>
    <basicUdiDi>B-08908020139507</basicUdiDi>
    <tradeName>Truenat HLA-B27</tradeName>
    <deviceName>Truenat HLA-B27</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601380025</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:46.286Z</lastUpdated>
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    <udiDi>08908007989842</udiDi>
    <basicUdiDi>B-08908007989842</basicUdiDi>
    <tradeName>Truenat HLA-B27</tradeName>
    <deviceName>Truenat HLA-B27</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601380050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:08.118Z</lastUpdated>
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    <udiDi>08908007989835</udiDi>
    <basicUdiDi>B-08908007989835</basicUdiDi>
    <tradeName>Truenat HLA-B27</tradeName>
    <deviceName>Truenat HLA-B27</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601380020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:07.310Z</lastUpdated>
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    <udiDi>08908007989828</udiDi>
    <basicUdiDi>B-08908007989828</basicUdiDi>
    <tradeName>Truenat HLA-B27</tradeName>
    <deviceName>Truenat HLA-B27</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601380005, 601380020, 601380025, 601380050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:05.722Z</lastUpdated>
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    <udiDi>08809115907356</udiDi>
    <basicUdiDi>B-08809115907356</basicUdiDi>
    <tradeName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</tradeName>
    <deviceName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-20.02B006-ABI</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:02.391Z</lastUpdated>
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    <udiDi>08809115907349</udiDi>
    <basicUdiDi>B-08809115907349</basicUdiDi>
    <tradeName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</tradeName>
    <deviceName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-20.02B006-ABF</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:01.573Z</lastUpdated>
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    <udiDi>08809115904355</udiDi>
    <basicUdiDi>B-08809115904355</basicUdiDi>
    <tradeName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</tradeName>
    <deviceName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
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    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-20.02B006-CFX</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:58:00.994Z</lastUpdated>
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    <tradeName>GeneFinder HLA-B*57:01 RealAmp Kit</tradeName>
    <deviceName>GeneFinder HLA-B*57:01 RealAmp Kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-22.02B050</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:59.393Z</lastUpdated>
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    <udiDi>08809115900555</udiDi>
    <basicUdiDi>B-08809115900555</basicUdiDi>
    <tradeName>GeneFinder HLA-ABDR RealAmp Kit</tradeName>
    <deviceName>GeneFinder HLA-ABDR RealAmp Kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-10.02B020-ABI</reference>
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    <lastUpdated>2026-07-10T08:56:48.083Z</lastUpdated>
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    <udiDi>08800323057109</udiDi>
    <basicUdiDi>B-08800323057109</basicUdiDi>
    <tradeName>GeneFinder HLA-B*51 RealAmp Kit</tradeName>
    <deviceName>GeneFinder HLA-B*51 RealAmp Kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-09.02B100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:22:47.314Z</lastUpdated>
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    <tradeName>Genvinset® HFE C282Y 96 tests</tradeName>
    <deviceName>Genvinset® HFE C282Y 96 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
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    <lastUpdated>2026-07-07T21:55:34.687Z</lastUpdated>
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    <tradeName>Genvinset® HFE H63D 96 tests</tradeName>
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    <tradeName>Genvinset® MTHFR A1298C 96 tests</tradeName>
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    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:28.642Z</lastUpdated>
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