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<eudamedExport entity="devices">
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    <udiDi>06942609201096</udiDi>
    <basicUdiDi>B-06942609201096</basicUdiDi>
    <tradeName>HbA1c CLIA</tradeName>
    <deviceName>HbA1c CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHB83K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:29:55.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201089</udiDi>
    <basicUdiDi>B-06942609201089</basicUdiDi>
    <tradeName>HbA1c CLIA</tradeName>
    <deviceName>HbA1c CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHB83K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:29:47.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201072</udiDi>
    <basicUdiDi>B-06942609201072</basicUdiDi>
    <tradeName>HbA1c CLIA</tradeName>
    <deviceName>HbA1c CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHB83K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:29:44.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201065</udiDi>
    <basicUdiDi>B-06942609201065</basicUdiDi>
    <tradeName>GH CLIA</tradeName>
    <deviceName>GH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGH72K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:29:37.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201058</udiDi>
    <basicUdiDi>B-06942609201058</basicUdiDi>
    <tradeName>GH CLIA</tradeName>
    <deviceName>GH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGH72K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:29:26.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201041</udiDi>
    <basicUdiDi>B-06942609201041</basicUdiDi>
    <tradeName>GH CLIA</tradeName>
    <deviceName>GH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGH72K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:29:18.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201034</udiDi>
    <basicUdiDi>B-06942609201034</basicUdiDi>
    <tradeName>GH CLIA</tradeName>
    <deviceName>GH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGH72K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:29:15.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201027</udiDi>
    <basicUdiDi>B-06942609201027</basicUdiDi>
    <tradeName>FSH CLIA</tradeName>
    <deviceName>FSH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFS01K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:29:04.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201010</udiDi>
    <basicUdiDi>B-06942609201010</basicUdiDi>
    <tradeName>FSH CLIA</tradeName>
    <deviceName>FSH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFS01K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:28:54.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609201003</udiDi>
    <basicUdiDi>B-06942609201003</basicUdiDi>
    <tradeName>FSH CLIA</tradeName>
    <deviceName>FSH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFS01K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:28:46.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200990</udiDi>
    <basicUdiDi>B-06942609200990</basicUdiDi>
    <tradeName>FSH CLIA</tradeName>
    <deviceName>FSH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFS01K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:28:42.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200983</udiDi>
    <basicUdiDi>B-06942609200983</basicUdiDi>
    <tradeName>FER CLIA</tradeName>
    <deviceName>FER CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFR08K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:28:35.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200976</udiDi>
    <basicUdiDi>B-06942609200976</basicUdiDi>
    <tradeName>FER CLIA</tradeName>
    <deviceName>FER CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFR08K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:28:19.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200969</udiDi>
    <basicUdiDi>B-06942609200969</basicUdiDi>
    <tradeName>FER CLIA</tradeName>
    <deviceName>FER CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFR08K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:28:12.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200952</udiDi>
    <basicUdiDi>B-06942609200952</basicUdiDi>
    <tradeName>FER CLIA</tradeName>
    <deviceName>FER CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFR08K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:28:08.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200945</udiDi>
    <basicUdiDi>B-06942609200945</basicUdiDi>
    <tradeName>FDP CLIA</tradeName>
    <deviceName>FDP CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFP36K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:28:00.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200938</udiDi>
    <basicUdiDi>B-06942609200938</basicUdiDi>
    <tradeName>FDP CLIA</tradeName>
    <deviceName>FDP CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFP36K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:27:49.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200921</udiDi>
    <basicUdiDi>B-06942609200921</basicUdiDi>
    <tradeName>FDP CLIA</tradeName>
    <deviceName>FDP CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFP36K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:27:38.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200914</udiDi>
    <basicUdiDi>B-06942609200914</basicUdiDi>
    <tradeName>FDP CLIA</tradeName>
    <deviceName>FDP CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFP36K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:27:34.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200907</udiDi>
    <basicUdiDi>B-06942609200907</basicUdiDi>
    <tradeName>FA CLIA</tradeName>
    <deviceName>FA CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFA63K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:27:26.785Z</lastUpdated>
  </row>
</eudamedExport>