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<eudamedExport entity="devices">
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    <udiDi>06942609200693</udiDi>
    <basicUdiDi>B-06942609200693</basicUdiDi>
    <tradeName>CT CLIA</tradeName>
    <deviceName>CT 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCT74K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:24:31.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200686</udiDi>
    <basicUdiDi>B-06942609200686</basicUdiDi>
    <tradeName>CT CLIA</tradeName>
    <deviceName>CT 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCT74K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:24:27.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200679</udiDi>
    <basicUdiDi>B-06942609200679</basicUdiDi>
    <tradeName>CT CLIA</tradeName>
    <deviceName>CT 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCT74K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:24:24.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200662</udiDi>
    <basicUdiDi>B-06942609200662</basicUdiDi>
    <tradeName>Cortisol CLIA</tradeName>
    <deviceName>Cortisol 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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCT09K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:24:22.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200631</udiDi>
    <basicUdiDi>B-06942609200631</basicUdiDi>
    <tradeName>Cortisol CLIA</tradeName>
    <deviceName>Cortisol 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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCT09K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:22:13.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200655</udiDi>
    <basicUdiDi>B-06942609200655</basicUdiDi>
    <tradeName>Cortisol CLIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCT09K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:22:10.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200624</udiDi>
    <basicUdiDi>B-06942609200624</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName>Anti-CCP 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:22:06.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200648</udiDi>
    <basicUdiDi>B-06942609200648</basicUdiDi>
    <tradeName>Cortisol CLIA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCT09K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:22:04.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200617</udiDi>
    <basicUdiDi>B-06942609200617</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName>Anti-CCP 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:57.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200600</udiDi>
    <basicUdiDi>B-06942609200600</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName>Anti-CCP 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:50.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200594</udiDi>
    <basicUdiDi>B-06942609200594</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName>Anti-CCP 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:47.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200587</udiDi>
    <basicUdiDi>B-06942609200587</basicUdiDi>
    <tradeName>C-Peptide CLIA</tradeName>
    <deviceName>C-Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP10K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:40.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200570</udiDi>
    <basicUdiDi>B-06942609200570</basicUdiDi>
    <tradeName>C-Peptide CLIA</tradeName>
    <deviceName>C-Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP10K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:30.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200563</udiDi>
    <basicUdiDi>B-06942609200563</basicUdiDi>
    <tradeName>C-Peptide CLIA</tradeName>
    <deviceName>C-Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP10K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:24.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200556</udiDi>
    <basicUdiDi>B-06942609200556</basicUdiDi>
    <tradeName>CK-MB CLIA</tradeName>
    <deviceName>CK-MB 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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCK13K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:21.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200549</udiDi>
    <basicUdiDi>B-06942609200549</basicUdiDi>
    <tradeName>CK-MB CLIA</tradeName>
    <deviceName>CK-MB 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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCK13K3FN</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:14.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200532</udiDi>
    <basicUdiDi>B-06942609200532</basicUdiDi>
    <tradeName>CK-MB CLIA</tradeName>
    <deviceName>CK-MB 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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCK13K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:21:04.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200525</udiDi>
    <basicUdiDi>B-06942609200525</basicUdiDi>
    <tradeName>C-Peptide CLIA</tradeName>
    <deviceName>C-Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP10K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:20:59.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200518</udiDi>
    <basicUdiDi>B-06942609200518</basicUdiDi>
    <tradeName>CYFRA21-1 CLIA</tradeName>
    <deviceName>CYFRA21-1 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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCF31K2N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:20:54.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200501</udiDi>
    <basicUdiDi>B-06942609200501</basicUdiDi>
    <tradeName>CYFRA21-1 CLIA</tradeName>
    <deviceName>CYFRA21-1 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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCF31K3N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:20:47.551Z</lastUpdated>
  </row>
</eudamedExport>