<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-HAVAb706-AEA7</udiDi>
    <basicUdiDi>B-HAVAb706-AEA7</basicUdiDi>
    <tradeName>Anti-HAV Hepatitis A Virus Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HAVAb706-AE10Y, HAVAb706-AE10N, HAVAb706-AE20Y, HAVAb706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:07.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HBA1C-D06aFH</udiDi>
    <basicUdiDi>B-HBA1C-D06aFH</basicUdiDi>
    <tradeName>HbA1C Test Kit FIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA1C-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:06.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HbA1c-S601EZ</udiDi>
    <basicUdiDi>B-HbA1c-S601EZ</basicUdiDi>
    <tradeName>Glycohemoglobin A1c Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HbA1c-S6011Y,HbA1c-S6012Y,HbA1c-S6013Y,HbA1c-S6014Y,HbA1c-S6015Y,HbA1c-S6011N,HbA1c-S6012N,HbA1c-S6013N,HbA1c-S6014N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:06.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HbA1c601Q8</udiDi>
    <basicUdiDi>B-HbA1c601Q8</basicUdiDi>
    <tradeName>Glycohemoglobin A1c Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HbA1c6011Y, HbA1c6012Y, HbA1c6013Y, HbA1c6014Y, HbA1c6015Y, HbA1c6011N, HbA1c6012N, HbA1c6013N, HbA1c6014N, HbA1c6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:06.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HCG-D06a82</udiDi>
    <basicUdiDi>B-HCG-D06a82</basicUdiDi>
    <tradeName>β-HCG Test Kit FIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>β-HCG-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:06.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HCY601C3</udiDi>
    <basicUdiDi>B-HCY601C3</basicUdiDi>
    <tradeName>Homocysteine Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HCY6011Y, HCY6012Y, HCY6013Y, HCY6014Y, HCY6015Y, HCY6011N, HCY6012N, HCY6013N, HCY6014N, HCY6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:06.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HDL-C60185</udiDi>
    <basicUdiDi>B-HDL-C60185</basicUdiDi>
    <tradeName>High Density Lipoprotein Cholesterol Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HDL-C6011Y, HDL-C6012Y, HDL-C6013Y, HDL-C6014Y, HDL-C6015Y, HDL-C6011N, HDL-C6012N, HDL-C6013N, HDL-C6014N, HDL-C6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:05.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HE4706-AEFT</udiDi>
    <basicUdiDi>B-HE4706-AEFT</basicUdiDi>
    <tradeName>HE4 Human Epididymal Protein 4 (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HE4706-AE10Y, HE4706-AE10N, HE4706-AE20Y, HE4706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:05.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP-D02aQH</udiDi>
    <basicUdiDi>B-HP-D02aQH</basicUdiDi>
    <tradeName>H. Pylori Antibody Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HP-D02a, HP-D01a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:02.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP-F02aQX</udiDi>
    <basicUdiDi>B-HP-F02aQX</basicUdiDi>
    <tradeName>H. Pylori Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HP-F02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:02.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HpAb706-AEUN</udiDi>
    <basicUdiDi>B-HpAb706-AEUN</basicUdiDi>
    <tradeName>Hp Ab Helicobacter Pylori Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HpAb706-AE10Y, HpAb706-AE10N, HpAb706-AE20Y, HpAb706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:02.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HS-CRP6018H</udiDi>
    <basicUdiDi>B-HS-CRP6018H</basicUdiDi>
    <tradeName>High Sensitivity C-Reactive Protein Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HS-CRP6011Y,HS-CRP6012Y,HS-CRP6013Y,HS-CRP6014Y,HS-CRP6015Y,HS-CRP6011N,HS-CRP6012N,HS-CRP6013N,HS-CRP6014N,HS-CRP6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:02.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-hs-CRP706-AEUC</udiDi>
    <basicUdiDi>B-hs-CRP706-AEUC</basicUdiDi>
    <tradeName>hs-CRP High-sensitivity C-reactive Protein (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>hs-CRP706-AE10Y, hs-CRP706-AE10N, hs-CRP706-AE20Y, hs-CRP706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:02.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-hs-cTnI706-AEVQ</udiDi>
    <basicUdiDi>B-hs-cTnI706-AEVQ</basicUdiDi>
    <tradeName>cTn-I Cardiac Troponin I  (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>hs-cTnI706-AE10Y, hs-cTnI706-AE10N, hs-cTnI706-AE20Y, hs-cTnI706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:02.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-hs-cTnT706-AE3N</udiDi>
    <basicUdiDi>B-hs-cTnT706-AE3N</basicUdiDi>
    <tradeName>cTn-T  Cardiac Troponin T (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>hs-cTnT706-AE10Y, hs-cTnT706-AE10N, hs-cTnT706-AE20Y, hs-cTnT706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:02.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HSV-D02aN9</udiDi>
    <basicUdiDi>B-HSV-D02aN9</basicUdiDi>
    <tradeName>HSV IgG/IgM Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HSV-D02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:01.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HSV1IgG706-AEDG</udiDi>
    <basicUdiDi>B-HSV1IgG706-AEDG</basicUdiDi>
    <tradeName>HSV - 2 IgG Herpes Simplex Virus Type 2 IgG Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HSV2IgG706-AE10Y, HSV2IgG706-AE10N, HSV2IgG706-AE20Y, HSV2IgG706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:01.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HSV2IgG706-AEED</udiDi>
    <basicUdiDi>B-HSV2IgG706-AEED</basicUdiDi>
    <tradeName>HSV - 1  IgG Herpes Simplex Virus Type 1 IgG Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>HSV1IgG706-AE10Y, HSV1IgG706-AE10N, HSV1IgG706-AE20Y, HSV1IgG706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:01.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IgA601HV</udiDi>
    <basicUdiDi>B-IgA601HV</basicUdiDi>
    <tradeName>Immunoglobulin A Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>IgA6011Y, IgA6012Y, IgA6013Y, IgA6014Y, IgA6015Y, IgA6011N, IgA6012N, IgA6013N, IgA6014N, IgA6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:59:46.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IgE706-AEAC</udiDi>
    <basicUdiDi>B-IgE706-AEAC</basicUdiDi>
    <tradeName>TIgE Total Immunoglobulin E (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>IgE706-AE10Y, IgE706-AE10N, IgE706-AE20Y, IgE706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:59:46.734Z</lastUpdated>
  </row>
</eudamedExport>