<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-Cu6012G</udiDi>
    <basicUdiDi>B-Cu6012G</basicUdiDi>
    <tradeName>Copper 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>Cu6011Y, Cu6012Y, Cu6013Y, Cu6014Y, Cu6015Y, Cu6011N, Cu6012N, Cu6013N, Cu6014N, Cu6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:27.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CY21-1706-AEMQ</udiDi>
    <basicUdiDi>B-CY21-1706-AEMQ</basicUdiDi>
    <tradeName>CYFRA21-1 Cytokeratin 19 Fragments (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>CY21-1706-AE10Y, CY21-1706-AE10N, CY21-1706-AE20Y, CY21-1706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:26.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CYS-C601K6</udiDi>
    <basicUdiDi>B-CYS-C601K6</basicUdiDi>
    <tradeName>Cystatin C 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>CYS-C6011Y, CYS-C6012Y, CYS-C6013Y, CYS-C6014Y, CYS-C6015Y, CYS-C6011N, CYS-C6012N, CYS-C6013N, CYS-C6014N, CYS-C6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:26.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-D-D02aQT</udiDi>
    <basicUdiDi>B-D-D-D02aQT</basicUdiDi>
    <tradeName>D-Dimer  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>D-D-D02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:47.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-D-D06aR7</udiDi>
    <basicUdiDi>B-D-D-D06aR7</basicUdiDi>
    <tradeName>D-Dimer 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>D-D-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:47.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-D706-AE79</udiDi>
    <basicUdiDi>B-D-D706-AE79</basicUdiDi>
    <tradeName>D-Dimer (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>D-D706-AE10Y, D-D706-AE10N, D-D706-AE20Y, D-D706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:47.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DB-V601JR</udiDi>
    <basicUdiDi>B-DB-V601JR</basicUdiDi>
    <tradeName>Direct Bilirubin 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>DB-V6011Y, DB-V6012Y, DB-V6013Y, DB-V6014Y, DB-V6015Y, DB-V6011N, DB-V6012N, DB-V6013N, DB-V6014N, DB-V6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:39.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DB601QN</udiDi>
    <basicUdiDi>B-DB601QN</basicUdiDi>
    <tradeName>Direct Bilirubin 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>DB6011Y, DB6012Y, DB6013Y, DB6014Y, DB6015Y, DB6011N, DB6012N, DB6013N, DB6014N, DB6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:39.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEAB-D02aRS</udiDi>
    <basicUdiDi>B-DEAB-D02aRS</basicUdiDi>
    <tradeName>Dengue 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>DEAB-D02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:31.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEAB/DEAG-D35aTS</udiDi>
    <basicUdiDi>B-DEAB/DEAG-D35aTS</basicUdiDi>
    <tradeName>Dengue IgG/IgM/NS1 Combo 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>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEAB/DEAG-D35a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:31.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEAG-D02bTV</udiDi>
    <basicUdiDi>B-DEAG-D02bTV</basicUdiDi>
    <tradeName>Dengue NS1 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>DEAG-D02b</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:31.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DHEA-S706-AEK5</udiDi>
    <basicUdiDi>B-DHEA-S706-AEK5</basicUdiDi>
    <tradeName>DHEA-S Dehydroepiandrosterone Sulfate (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>DHEA-S706-AE10Y, DHEA-S706-AE10N, DHEA-S706-AE20Y, DHEA-S706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:10.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DIG706-AEQV</udiDi>
    <basicUdiDi>B-DIG706-AEQV</basicUdiDi>
    <tradeName>DIG Digoxin(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>DIG706-AE10Y, DIG706-AE10N, DIG706-AE20Y, DIG706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:09.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DOA-A104-005UV</udiDi>
    <basicUdiDi>B-DOA-A104-005UV</basicUdiDi>
    <tradeName>Multi-Drug Test Panel (AMP/BAR/BZO/COC/MDMA/MET/MOP/MTD/TCA/THC)</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>DOA-A104-005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:08.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DOA-A104-006UX</udiDi>
    <basicUdiDi>B-DOA-A104-006UX</basicUdiDi>
    <tradeName>Multi-Drug Test Panel (AMP/BAR/BZO/COC/MQL/MTD/OPI/PCP/PPX/THC)</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>DOA-A104-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:07.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DOA-A124-003VK</udiDi>
    <basicUdiDi>B-DOA-A124-003VK</basicUdiDi>
    <tradeName>Mult -Drug Test Panel (THC/MDMA/OXY/PCP/COC/MTD/TRA/BAR/BZO/MOP/MET/K2)</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>DOA-A124-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:07.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DOA-A124-007VT</udiDi>
    <basicUdiDi>B-DOA-A124-007VT</basicUdiDi>
    <tradeName>Multi-Drug Test Panel (COC/THC/MOP/OPI/COT/PCP/BZO/TCA/MDMA/TML/MTD/BAR)</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>DOA-A124-007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:07.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DOA-A127-002WJ</udiDi>
    <basicUdiDi>B-DOA-A127-002WJ</basicUdiDi>
    <tradeName>Multi-Drug Test Cup (AMP/COC/MET/OPI/THC/BZO/BUP/COT/KET/PCP/BAR/MDMA)</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>DOA-A127-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:07.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DOA-A134-002VW</udiDi>
    <basicUdiDi>B-DOA-A134-002VW</basicUdiDi>
    <tradeName>Multi-Drug Test Panel  (AMP/BZO/COC/MET/MDMA/ MOP/MTD/PCP/THC/SOMA/K2/K3/ETO)</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>DOA-A134-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:07.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DOA-A144-002WB</udiDi>
    <basicUdiDi>B-DOA-A144-002WB</basicUdiDi>
    <tradeName>Multi-Drug Test Panel (THC/AMP/BZO/CBD/MET/PGB/GAB/TML/LSD/COC/OPI/ETG/K2/KET)</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>DOA-A144-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:07.736Z</lastUpdated>
  </row>
</eudamedExport>