<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975022535127</udiDi>
    <basicUdiDi>69750225319113CEMM</basicUdiDi>
    <tradeName>06975022535127</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:43:22.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975022535141</udiDi>
    <basicUdiDi>69750225321111CEJL</basicUdiDi>
    <tradeName>06975022535141</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:43:22.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975022535158</udiDi>
    <basicUdiDi>69750225321111CEJL</basicUdiDi>
    <tradeName>06975022535158</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:43:22.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975022535165</udiDi>
    <basicUdiDi>69750225321111CEJL</basicUdiDi>
    <tradeName>06975022535165</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN603</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:43:22.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975022538555</udiDi>
    <basicUdiDi>69750225321111CEJL</basicUdiDi>
    <tradeName>06975022538555</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN605</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:43:22.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977565589926</udiDi>
    <basicUdiDi>6977565589952</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9922</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:54:07.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236613</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h600Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:51.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236620</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h600Max</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:51.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236637</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:51.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236644</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h800Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:51.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236651</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h800Max</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:51.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236668</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:51.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236675</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h1200Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:51.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236682</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h1200Max</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:51.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059015831194</udiDi>
    <basicUdiDi>805901583READERDX</basicUdiDi>
    <tradeName>Screen Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SCREEN ITALIA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000040460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069082</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1194-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:11:24.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059015834591</udiDi>
    <basicUdiDi>805901583READERDX</basicUdiDi>
    <tradeName>Screen Smart</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SCREEN ITALIA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000040460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069082</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1194</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:11:24.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059015834607</udiDi>
    <basicUdiDi>805901583READERDX</basicUdiDi>
    <tradeName>FC READER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SCREEN ITALIA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000040460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069082</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCR0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:11:24.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059015834614</udiDi>
    <basicUdiDi>805901583READERDX</basicUdiDi>
    <tradeName>FC READER PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SCREEN ITALIA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000040460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069082</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCR0002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:11:24.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3412490008115QS</udiDi>
    <basicUdiDi>B-3412490008115QS</basicUdiDi>
    <tradeName>Contour® XT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ascensia Diabetes Care Holdings AG</manufacturerName>
    <manufacturerSrn>CH-MF-000034124</manufacturerSrn>
    <authorisedRepresentativeName>Ascensia Diabetes Care Italy Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000025584</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90008115</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:02:42.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3412490008114QQ</udiDi>
    <basicUdiDi>B-3412490008114QQ</basicUdiDi>
    <tradeName>Contour® XT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ascensia Diabetes Care Holdings AG</manufacturerName>
    <manufacturerSrn>CH-MF-000034124</manufacturerSrn>
    <authorisedRepresentativeName>Ascensia Diabetes Care Italy Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000025584</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90008114</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:02:39.848Z</lastUpdated>
  </row>
</eudamedExport>