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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-PIVKA-Ⅱ -0450</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:05:58.096Z</lastUpdated>
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    <tradeName>INNODX PIVKA-II CMIA</tradeName>
    <deviceName>INNODX PIVKA-II CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-PIVKA-Ⅱ -02200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:05:56.909Z</lastUpdated>
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    <deviceName>INNODX PIVKA-II CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-PIVKA-Ⅱ -02100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:05:55.688Z</lastUpdated>
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    <tradeName>INNODX PIVKA-II CMIA</tradeName>
    <deviceName>INNODX PIVKA-II CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-PIVKA-Ⅱ -0250</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:04:50.857Z</lastUpdated>
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    <udiDi>06970150905880</udiDi>
    <basicUdiDi>697015090000083HE</basicUdiDi>
    <tradeName>PIVKA-II CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB2002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:45:50.681Z</lastUpdated>
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    <udiDi>06942028502606</udiDi>
    <basicUdiDi>B-06942028502606</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKAⅡ) Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKAⅡ) Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD2101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:59.088Z</lastUpdated>
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    <tradeName>HOKAPI™ PIVKA-II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010125601</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:49.889Z</lastUpdated>
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    <tradeName>HOKAPI™ PIVKA-II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010125001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:48.701Z</lastUpdated>
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    <tradeName>HOKAPI™ PIVKA-II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010125101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:47.502Z</lastUpdated>
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    <udiDi>06936595751406</udiDi>
    <basicUdiDi>B-06936595751406</basicUdiDi>
    <tradeName>Protein Induced By Vitamin K Absence or Antagonist-II Kit (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1219Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:56:45.090Z</lastUpdated>
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