<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FOB-F02aB9</udiDi>
    <basicUdiDi>B-FOB-F02aB9</basicUdiDi>
    <tradeName>FOB Rapid Test</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>FOB-F02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:53.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FOB-F06aBM</udiDi>
    <basicUdiDi>B-FOB-F06aBM</basicUdiDi>
    <tradeName>FOB 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>FOB-F06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:53.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Folate706-AENG</udiDi>
    <basicUdiDi>B-Folate706-AENG</basicUdiDi>
    <tradeName>Folate (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>Folate706-AE10Y, Folate706-AE10N, Folate706-AE20Y, Folate706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:53.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FSH-A02aEQ</udiDi>
    <basicUdiDi>B-FSH-A02aEQ</basicUdiDi>
    <tradeName>FSH One Step Menopause Test</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>FSH-A02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:34.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FSH-D06aFR</udiDi>
    <basicUdiDi>B-FSH-D06aFR</basicUdiDi>
    <tradeName>FSH 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>FSH-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:34.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FSH706-AEYS</udiDi>
    <basicUdiDi>B-FSH706-AEYS</basicUdiDi>
    <tradeName>FSH Follicle Stimulating Hormone (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>FSH706-AE10Y, FSH706-AE10N, FSH706-AE20Y, FSH706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:34.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT3-D06a86</udiDi>
    <basicUdiDi>B-FT3-D06a86</basicUdiDi>
    <tradeName>FT3 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>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT3-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:30.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT3706-AENR</udiDi>
    <basicUdiDi>B-FT3706-AENR</basicUdiDi>
    <tradeName>FT3 Free Triiodothyronine (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>FT3706-AE10Y, FT3706-AE10N, FT3706-AE20Y, FT3706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:30.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT4-D06a8K</udiDi>
    <basicUdiDi>B-FT4-D06a8K</basicUdiDi>
    <tradeName>FT4 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>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT4-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:30.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTesto706-AED3</udiDi>
    <basicUdiDi>B-FTesto706-AED3</basicUdiDi>
    <tradeName>FT Free Testosterone (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>FTesto706-AE10Y, FTesto706-AE10N, FTesto706-AE20Y, FTesto706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:30.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G-17706-AEK6</udiDi>
    <basicUdiDi>B-G-17706-AEK6</basicUdiDi>
    <tradeName>G-17 Gastrin-17 (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>G-17706-AE10Y, G-17706-AE10N, G-17706-AE20Y, G-17706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:01:18.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GDF-15706-AEQU</udiDi>
    <basicUdiDi>B-GDF-15706-AEQU</basicUdiDi>
    <tradeName>GDF-15 Growth Differentiation Factor-15 (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>GDF-15706-AE10Y, GDF-15706-AE10N, GDF-15706-AE20Y, GDF-15706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:33.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GGT601BX</udiDi>
    <basicUdiDi>B-GGT601BX</basicUdiDi>
    <tradeName>γ-Glutamyl Transferase 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>GGT6011Y, GGT6012Y, GGT6013Y, GGT6014Y, GGT6015Y, GGT6011N, GGT6012N, GGT6013N, GGT6014N, GGT6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:24.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GH706-AEZ5</udiDi>
    <basicUdiDi>B-GH706-AEZ5</basicUdiDi>
    <tradeName>GH Growth hormone (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>GH706-AE10Y, GH706-AE10N, GH706-AE20Y, GH706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:24.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GHB-A01a6X</udiDi>
    <basicUdiDi>B-GHB-A01a6X</basicUdiDi>
    <tradeName>GHB One Step Gamma-hydroxybutyrate 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>"GHB-A01a, GHB-A04a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:24.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GLU-HK601BA</udiDi>
    <basicUdiDi>B-GLU-HK601BA</basicUdiDi>
    <tradeName>Glucose 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>GLU-HK6011Y,GLU-HK6012Y,GLU-HK6013Y,GLU-HK6014Y,GLU-HK6015Y,GLU-HK6011N,GLU-HK6012N,GLU-HK6013N,GLU-HK6014N,GLU-HK6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GLU-OX601GJ</udiDi>
    <basicUdiDi>B-GLU-OX601GJ</basicUdiDi>
    <tradeName>Glucose 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>GLU-OX6011Y,GLU-OX6012Y,GLU-OX6013Y,GLU-OX6014Y,GLU-OX6015Y,GLU-OX6011N,GLU-OX6012N,GLU-OX6013N,GLU-OX6014N,GLU-OX6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-H-FABP-D06aBK</udiDi>
    <basicUdiDi>B-H-FABP-D06aBK</basicUdiDi>
    <tradeName>H-FABP 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>H-FABP-D06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:18.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-H-FABP706-AE9R</udiDi>
    <basicUdiDi>B-H-FABP706-AE9R</basicUdiDi>
    <tradeName>H-FABP Heart-type Fatty Acid-binding 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>H-FABP706-AE10Y, H-FABP706-AE10N, H-FABP706-AE20Y, H-FABP706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:18.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HAV-D02aCP</udiDi>
    <basicUdiDi>B-HAV-D02aCP</basicUdiDi>
    <tradeName>Hepatitis A Virus 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>HAV-D02a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:07.474Z</lastUpdated>
  </row>
</eudamedExport>