<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-MAU-A02aEL</udiDi>
    <basicUdiDi>B-MAU-A02aEL</basicUdiDi>
    <tradeName>MAU 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>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAU-A02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:22.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAU-A06aEY</udiDi>
    <basicUdiDi>B-MAU-A06aEY</basicUdiDi>
    <tradeName>MAU 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>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAU-A06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:22.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MB601TR</udiDi>
    <basicUdiDi>B-MB601TR</basicUdiDi>
    <tradeName>Myoglobin 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>MB6011Y, MB6012Y, MB6013Y, MB6014Y, MB6015Y, MB6011N, MB6012N, MB6013N, MB6014N, MB6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:22.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Mg6012U</udiDi>
    <basicUdiDi>B-Mg6012U</basicUdiDi>
    <tradeName>Magnesium 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>Mg6011Y, Mg6012Y, Mg6013Y, Mg6014Y, Mg6015Y, Mg6011N, Mg6012N, Mg6013N, Mg6014N, Mg6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:18.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MYO-D06aRX</udiDi>
    <basicUdiDi>B-MYO-D06aRX</basicUdiDi>
    <tradeName>MYO 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>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYO-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:07.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MYO706-AED7</udiDi>
    <basicUdiDi>B-MYO706-AED7</basicUdiDi>
    <tradeName>MYO Myoglobin (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>MYO706-AE10Y, MYO706-AE10N, MYO706-AE20Y, MYO706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:07.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Na601ZS</udiDi>
    <basicUdiDi>B-Na601ZS</basicUdiDi>
    <tradeName>Sodium 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>Na6011Y, Na6012Y, Na6013Y, Na6014Y, Na6015Y, Na6011N, Na6012N, Na6013N, Na6014N, Na6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:07.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NOV-F02aQ5</udiDi>
    <basicUdiDi>B-NOV-F02aQ5</basicUdiDi>
    <tradeName>Norovirus 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>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOV-F02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:58.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NSE706-AE52</udiDi>
    <basicUdiDi>B-NSE706-AE52</basicUdiDi>
    <tradeName>NSE Neuron-Specific Enolase (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>NSE706-AE10Y, NSE706-AE10N, NSE706-AE20Y, NSE706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:30.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NT-proBNP-D06a9N</udiDi>
    <basicUdiDi>B-NT-proBNP-D06a9N</basicUdiDi>
    <tradeName>NT-proBNP 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>NT-proBNP-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:17.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NT-proBNP706-AE3K</udiDi>
    <basicUdiDi>B-NT-proBNP706-AE3K</basicUdiDi>
    <tradeName>NT-proBNP N-Terminal Pro-Brain Natriuretic Peptide (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>NT-proBNP706-AE10Y, NT-proBNP706-AE10N, NT-proBNP706-AE20Y, NT-proBNP706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:17.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-P-AMY601C7</udiDi>
    <basicUdiDi>B-P-AMY601C7</basicUdiDi>
    <tradeName>Pancreatic Amylase 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>P-AMY6011Y, P-AMY6012Y, P-AMY6013Y, P-AMY6014Y, P-AMY6015Y, P-AMY6011N, P-AMY6012N, P-AMY6013N, P-AMY6014N, P-AMY6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:57.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PA601UK</udiDi>
    <basicUdiDi>B-PA601UK</basicUdiDi>
    <tradeName>Prealbumin 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>PA6011Y, PA6012Y, PA6013Y, PA6014Y, PA6015Y, PA6011N, PA6012N, PA6013N, PA6014N, PA6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:44.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PB706-AE3D</udiDi>
    <basicUdiDi>B-PB706-AE3D</basicUdiDi>
    <tradeName>PB Phenobarbital(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>PB706-AE10Y, PB706-AE10N, PB706-AE20Y, PB706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:44.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCT-D02aHP</udiDi>
    <basicUdiDi>B-PCT-D02aHP</basicUdiDi>
    <tradeName>PCT 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>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT-D02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:44.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCT-D06aJ3</udiDi>
    <basicUdiDi>B-PCT-D06aJ3</basicUdiDi>
    <tradeName>PCT 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>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-PCT-D06aJ3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:44.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCT/IL-6-D26a9Q</udiDi>
    <basicUdiDi>B-PCT/IL-6-D26a9Q</basicUdiDi>
    <tradeName>PCT/IL-6 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>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT/IL-6-D26a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:44.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCT706-AE4X</udiDi>
    <basicUdiDi>B-PCT706-AE4X</basicUdiDi>
    <tradeName>PCT Procalcitonin (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>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT706-AE10Y, PCT706-AE10N, PCT706-AE20Y, PCT706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:44.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PDG-A01aC7</udiDi>
    <basicUdiDi>B-PDG-A01aC7</basicUdiDi>
    <tradeName>PDG One Step Ovulation 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>FERTILITY FUNCTION HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PDG-A01a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:43.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PGI706-AEZD</udiDi>
    <basicUdiDi>B-PGI706-AEZD</basicUdiDi>
    <tradeName>PGI Pepsinogen l (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>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGI706-AE10Y, PGI706-AE10N, PGI706-AE20Y, PGI706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:42.431Z</lastUpdated>
  </row>
</eudamedExport>