<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942359549691</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>CMB2003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:59.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359517218</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>CMB2007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:48:17.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481164413</udiDi>
    <basicUdiDi>49874814987481164413UA</basicUdiDi>
    <tradeName>μTASWako DCP</tradeName>
    <deviceName>μTASWako DCP, μTASWako DCP Calibrator Set, μTASWako DCP Control L, μTASWako DCP Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</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>995-60701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:43.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PIVKA-II706-AEF7</udiDi>
    <basicUdiDi>B-PIVKA-II706-AEF7</basicUdiDi>
    <tradeName>PIVKA-II Protein Induced by Vitamin K Absence or Antagonist-II (CLIA)</tradeName>
    <deviceName>PIVKA-II Protein Induced by Vitamin K Absence or Antagonist-II (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>PIVKA-II706-AE10Y, PIVKA-II706-AE10N, PIVKA-II706-AE20Y, PIVKA-II706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:45:36.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIVKA-II-05100C2</udiDi>
    <basicUdiDi>B-KR-PIVKA-II-05100C2</basicUdiDi>
    <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>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>KR-PIVKA-II-05100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:45:28.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIVKA-II-0250LA</udiDi>
    <basicUdiDi>B-KR-PIVKA-II-0250LA</basicUdiDi>
    <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>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>KR-PIVKA-II-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:45:27.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIVKA-II-02200BJ</udiDi>
    <basicUdiDi>B-KR-PIVKA-II-02200BJ</basicUdiDi>
    <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>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>KR-PIVKA-II-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:45:26.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIVKA-II-02100BD</udiDi>
    <basicUdiDi>B-KR-PIVKA-II-02100BD</basicUdiDi>
    <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>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>KR-PIVKA-II-02100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:45:25.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185401001</udiDi>
    <basicUdiDi>B-14562185401001</basicUdiDi>
    <tradeName>14562185401001</tradeName>
    <deviceName>CL AIA-PACK PIVKA-II ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</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>0029244</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:09:44.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400998</udiDi>
    <basicUdiDi>B-14562185400998</basicUdiDi>
    <tradeName>14562185400998</tradeName>
    <deviceName>CL AIA-PACK PIVKA-II TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</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>0029144</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:09:44.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189213088</udiDi>
    <basicUdiDi>B-14560189213088</basicUdiDi>
    <tradeName>14560189213088</tradeName>
    <deviceName>ST AIA-PACK PIVKA-II</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</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>Artık piyasada değil</deviceStatus>
    <reference>0025233</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:20.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753470534</udiDi>
    <basicUdiDi>B-06976753470534</basicUdiDi>
    <tradeName>Protin induced by Vitamin K Absence or Antagonist -Ⅱ（PIVKA-Ⅱ）Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>C2KH014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:56:19.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971792051379</udiDi>
    <basicUdiDi>B-06971792051379</basicUdiDi>
    <tradeName>Protin induced by Vitamin K Absence or Antagonist -Ⅱ（PIVKA-Ⅱ）Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>C2KA021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:53:19.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716405363</udiDi>
    <basicUdiDi>693971640125LC</basicUdiDi>
    <tradeName>HOKAPI™ PIVKA-II</tradeName>
    <deviceName>HOKAPI™ PIVKA-II</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>IVDR 2017/746</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010125401</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:37.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236491</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</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>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:15.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236484</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</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>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:14.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236477</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</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>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:13.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236460</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</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>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:06.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236453</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</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>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:04.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973600799732</udiDi>
    <basicUdiDi>697360079025JX</basicUdiDi>
    <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 -05100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:05:59.287Z</lastUpdated>
  </row>
</eudamedExport>