<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-KR-PGI-01100C27</udiDi>
    <basicUdiDi>B-KR-PGI-01100C27</basicUdiDi>
    <tradeName>INNODX PGI 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-PGⅠ-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PGII-01100CG9</udiDi>
    <basicUdiDi>B-KR-PGII-01100CG9</basicUdiDi>
    <tradeName>INNODX PG II 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-PG Ⅱ-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIIINP-01100CD9</udiDi>
    <basicUdiDi>B-KR-PIIINP-01100CD9</basicUdiDi>
    <tradeName>INNODX PIIINP 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-PⅢNP-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIVKA-II-02100BD</udiDi>
    <basicUdiDi>B-KR-PIVKA-II-02100BD</basicUdiDi>
    <tradeName>INNODX PIVKA-II 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-PIVKA-II-02100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIVKA-II-02200BJ</udiDi>
    <basicUdiDi>B-KR-PIVKA-II-02200BJ</basicUdiDi>
    <tradeName>INNODX PIVKA-II 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-PIVKA-II-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIVKA-II-0250LA</udiDi>
    <basicUdiDi>B-KR-PIVKA-II-0250LA</basicUdiDi>
    <tradeName>INNODX PIVKA-II 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-PIVKA-II-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PIVKA-II-05100C2</udiDi>
    <basicUdiDi>B-KR-PIVKA-II-05100C2</basicUdiDi>
    <tradeName>INNODX PIVKA-II 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-PIVKA-II-05100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PRL-01100CBV</udiDi>
    <basicUdiDi>B-KR-PRL-01100CBV</basicUdiDi>
    <tradeName>INNODX PRL 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-PRL-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Prog-01100CRF</udiDi>
    <basicUdiDi>B-KR-Prog-01100CRF</basicUdiDi>
    <tradeName>INNODX Prog 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-Prog-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-ProGRP-01100TR</udiDi>
    <basicUdiDi>B-KR-ProGRP-01100TR</basicUdiDi>
    <tradeName>INNODX ProGRP 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-ProGRP-01100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-ProGRP-02200U5</udiDi>
    <basicUdiDi>B-KR-ProGRP-02200U5</basicUdiDi>
    <tradeName>INNODX ProGRP 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-ProGRP-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-ProGRP-02507A</udiDi>
    <basicUdiDi>B-KR-ProGRP-02507A</basicUdiDi>
    <tradeName>INNODX ProGRP 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-ProGRP-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-ProGRP-05100UM</udiDi>
    <basicUdiDi>B-KR-ProGRP-05100UM</basicUdiDi>
    <tradeName>INNODX ProGRP 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-ProGRP-05100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-SCC-01100CWD</udiDi>
    <basicUdiDi>B-KR-SCC-01100CWD</basicUdiDi>
    <tradeName>INNODX SCC 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-SCC-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-ST2STAT-01100WM</udiDi>
    <basicUdiDi>B-KR-ST2STAT-01100WM</basicUdiDi>
    <tradeName>INNODX ST2 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-ST2 STAT-01100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-ST2STAT-02200WZ</udiDi>
    <basicUdiDi>B-KR-ST2STAT-02200WZ</basicUdiDi>
    <tradeName>INNODX ST2 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-ST2 STAT-02200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-ST2STAT-02505Q</udiDi>
    <basicUdiDi>B-KR-ST2STAT-02505Q</basicUdiDi>
    <tradeName>INNODX ST2 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-ST2 STAT-0250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-ST2STAT-05100XH</udiDi>
    <basicUdiDi>B-KR-ST2STAT-05100XH</basicUdiDi>
    <tradeName>INNODX ST2 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-ST2 STAT-05100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-T-B-HCG-01100C2Y</udiDi>
    <basicUdiDi>B-KR-T-B-HCG-01100C2Y</basicUdiDi>
    <tradeName>INNODX T-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>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-T-β-HCG-01100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TB-IGRA-01020C65</udiDi>
    <basicUdiDi>B-KR-TB-IGRA-01020C65</basicUdiDi>
    <tradeName>INNODX TB-IGRA 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-TB-IGRA-01020C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:34.225Z</lastUpdated>
  </row>
</eudamedExport>