<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-KR-HEV-02100CZG</udiDi>
    <basicUdiDi>B-KR-HEV-02100CZG</basicUdiDi>
    <tradeName>INNODX HEV IgM CMIA</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-HEV-02100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:41.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-hGH-01100AB</udiDi>
    <basicUdiDi>B-KR-hGH-01100AB</basicUdiDi>
    <tradeName>INNODX hGH CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-hGH-01100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:41.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-hGH-02200AP</udiDi>
    <basicUdiDi>B-KR-hGH-02200AP</basicUdiDi>
    <tradeName>INNODX hGH CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-hGH-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:41.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-hGH-0250AW</udiDi>
    <basicUdiDi>B-KR-hGH-0250AW</basicUdiDi>
    <tradeName>INNODX hGH CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-hGH-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:41.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Hs-CRP-01100CH3</udiDi>
    <basicUdiDi>B-KR-Hs-CRP-01100CH3</basicUdiDi>
    <tradeName>INNODX Hs-CRP CMIA</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INNODX Hs-CRP CMIA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Hs-cTnTSTAT-02200BM</udiDi>
    <basicUdiDi>B-KR-Hs-cTnTSTAT-02200BM</basicUdiDi>
    <tradeName>INNODX Hs-cTnT STAT CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Hs-cTnT STAT-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Hs-cTnTSTAT-0250J4</udiDi>
    <basicUdiDi>B-KR-Hs-cTnTSTAT-0250J4</basicUdiDi>
    <tradeName>INNODX Hs-cTnT STAT CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Hs-cTnT STAT-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Insulin-01100CT9</udiDi>
    <basicUdiDi>B-KR-Insulin-01100CT9</basicUdiDi>
    <tradeName>INNODX Insulin CMIA</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Insulin-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-iPTH-01100CP</udiDi>
    <basicUdiDi>B-KR-iPTH-01100CP</basicUdiDi>
    <tradeName>INNODX iPTH CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-iPTH-01100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-iPTH-02200D3</udiDi>
    <basicUdiDi>B-KR-iPTH-02200D3</basicUdiDi>
    <tradeName>D-KR-iPTH-02200D3</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-iPTH-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-iPTH-0250YP</udiDi>
    <basicUdiDi>B-KR-iPTH-0250YP</basicUdiDi>
    <tradeName>INNODX iPTH CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-iPTH-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-LH-01100CEZ</udiDi>
    <basicUdiDi>B-KR-LH-01100CEZ</basicUdiDi>
    <tradeName>INNODX LH CMIA</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-LH-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-LN-01100CJK</udiDi>
    <basicUdiDi>B-KR-LN-01100CJK</basicUdiDi>
    <tradeName>INNODX LN CMIA</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-LN-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:35.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Myo-031007T</udiDi>
    <basicUdiDi>B-KR-Myo-031007T</basicUdiDi>
    <tradeName>INNODX Myo STAT CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Myo-03100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-MyoSTAT-02200HV</udiDi>
    <basicUdiDi>B-KR-MyoSTAT-02200HV</basicUdiDi>
    <tradeName>INNODX Myo STAT CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Myo STAT-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-MyoSTAT-0250FT</udiDi>
    <basicUdiDi>B-KR-MyoSTAT-0250FT</basicUdiDi>
    <tradeName>INNODX Myo STAT CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Myo STAT-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-NBNP-03100FQ</udiDi>
    <basicUdiDi>B-KR-NBNP-03100FQ</basicUdiDi>
    <tradeName>INNODX NBNP STAT CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-NBNP-03100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-NBNPSTAT-022008A</udiDi>
    <basicUdiDi>B-KR-NBNPSTAT-022008A</basicUdiDi>
    <tradeName>INNODX NBNP STAT CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-NBNP STAT-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-NBNPSTAT-0250A8</udiDi>
    <basicUdiDi>B-KR-NBNPSTAT-0250A8</basicUdiDi>
    <tradeName>INNODX NBNP STAT CMIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-NBNP STAT-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-NSE-01100C6M</udiDi>
    <basicUdiDi>B-KR-NSE-01100C6M</basicUdiDi>
    <tradeName>INNODX NSE CMIA</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-NSE-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.634Z</lastUpdated>
  </row>
</eudamedExport>