<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-KR-CT-02200M6</udiDi>
    <basicUdiDi>B-KR-CT-02200M6</basicUdiDi>
    <tradeName>INNODX CT 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-CT-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-CT-0250TR</udiDi>
    <basicUdiDi>B-KR-CT-0250TR</basicUdiDi>
    <tradeName>INNODX CT 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-CT-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-cTnT-03100VE</udiDi>
    <basicUdiDi>B-KR-cTnT-03100VE</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-cTnT-03100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Cy21-1-01100CT6</udiDi>
    <basicUdiDi>B-KR-Cy21-1-01100CT6</basicUdiDi>
    <tradeName>INNODX Cy21-1 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-Cy21-1-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-E2-01100CVE</udiDi>
    <basicUdiDi>B-KR-E2-01100CVE</basicUdiDi>
    <tradeName>INNODX E2 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-E2-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-EBV-01100CU9</udiDi>
    <basicUdiDi>B-KR-EBV-01100CU9</basicUdiDi>
    <tradeName>INNODX EBV EBNA1 IgA 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-EBV-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-EBV-02100CUL</udiDi>
    <basicUdiDi>B-KR-EBV-02100CUL</basicUdiDi>
    <tradeName>INNODX EBV VCA IgA 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-EBV-02100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-F-B-HCG-01100CG3</udiDi>
    <basicUdiDi>B-KR-F-B-HCG-01100CG3</basicUdiDi>
    <tradeName>INNODX F-β-HCG 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-F-β-HCG-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Ferritin-01100CQW</udiDi>
    <basicUdiDi>B-KR-Ferritin-01100CQW</basicUdiDi>
    <tradeName>INNODX Ferritin 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-Ferritin-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FSH-01100CZ3</udiDi>
    <basicUdiDi>B-KR-FSH-01100CZ3</basicUdiDi>
    <tradeName>INNODX FSH 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-FSH-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-01100CMW</udiDi>
    <basicUdiDi>B-KR-FT3-01100CMW</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-01200JM</udiDi>
    <basicUdiDi>B-KR-FT3-01200JM</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-01200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-01300JS</udiDi>
    <basicUdiDi>B-KR-FT3-01300JS</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-01300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-0150Q8</udiDi>
    <basicUdiDi>B-KR-FT3-0150Q8</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-0150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-02100JP</udiDi>
    <basicUdiDi>B-KR-FT3-02100JP</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-02100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-02200JU</udiDi>
    <basicUdiDi>B-KR-FT3-02200JU</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-02300JZ</udiDi>
    <basicUdiDi>B-KR-FT3-02300JZ</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-02300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-0250QD</udiDi>
    <basicUdiDi>B-KR-FT3-0250QD</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-03100JW</udiDi>
    <basicUdiDi>B-KR-FT3-03100JW</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-03100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-04100K5</udiDi>
    <basicUdiDi>B-KR-FT3-04100K5</basicUdiDi>
    <tradeName>INNODX FT3 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-FT3-04100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:42.124Z</lastUpdated>
  </row>
</eudamedExport>