<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455-GLU-M3288</udiDi>
    <basicUdiDi>B-CNMF000014455-GLU-M3288</basicUdiDi>
    <tradeName>D-CNMF000014455-GLU-M3288</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M32</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:28.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GLU-M3186</udiDi>
    <basicUdiDi>B-CNMF000014455-GLU-M3186</basicUdiDi>
    <tradeName>D-CNMF000014455-GLU-M3186</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M31</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:28.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GLU-M2387</udiDi>
    <basicUdiDi>B-CNMF000014455-GLU-M2387</basicUdiDi>
    <tradeName>D-CNMF000014455-GLU-M2387</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M23</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:27.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GLU-M2285</udiDi>
    <basicUdiDi>B-CNMF000014455-GLU-M2285</basicUdiDi>
    <tradeName>D-CNMF000014455-GLU-M2285</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M22</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:26.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GLU-M2183</udiDi>
    <basicUdiDi>B-CNMF000014455-GLU-M2183</basicUdiDi>
    <tradeName>D-CNMF000014455-GLU-M2183</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M21</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:22.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GLU-M1282</udiDi>
    <basicUdiDi>B-CNMF000014455-GLU-M1282</basicUdiDi>
    <tradeName>D-CNMF000014455-GLU-M1282</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:21.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-A1C-M41L8</udiDi>
    <basicUdiDi>B-CNMF000014455-A1C-M41L8</basicUdiDi>
    <tradeName>D-CNMF000014455-A1C-M41L8</tradeName>
    <deviceName>A1cChek Express Glycohemoglobin Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-M41</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:11.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BX-SG0DVL</udiDi>
    <basicUdiDi>B-BX-SG0DVL</basicUdiDi>
    <tradeName>BeneCheck Supreme Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX-SG0D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:30:17.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BX-SG00UE</udiDi>
    <basicUdiDi>B-BX-SG00UE</basicUdiDi>
    <tradeName>BeneCheck Supreme Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX-SG00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:30:15.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BSG01D-29M</udiDi>
    <basicUdiDi>B-BSG01D-29M</basicUdiDi>
    <tradeName>BeneCheck Uni Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSG01D-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:31.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BSG010-26N</udiDi>
    <basicUdiDi>B-BSG010-26N</basicUdiDi>
    <tradeName>BeneCheck Uni Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSG010-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:30.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BKM21-2-BNY</udiDi>
    <basicUdiDi>B-BKM21-2-BNY</basicUdiDi>
    <tradeName>BeneCheck Plus pro Glucose Monitoring System</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BKM21-2-B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:26:45.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BKM21-2-ANW</udiDi>
    <basicUdiDi>B-BKM21-2-ANW</basicUdiDi>
    <tradeName>BeneCheck Plus Pro Glucose Monitoring System</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BKM21-2-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:26:40.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BC010DZ5</udiDi>
    <basicUdiDi>B-BC010DZ5</basicUdiDi>
    <tradeName>SANcheck ABEL GK Blood Glucose &amp; β-Ketone Monitoring System</tradeName>
    <deviceName>Blood glucose and β-ketone dual-monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020106019099</emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC010D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:23:22.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BC0100XX</udiDi>
    <basicUdiDi>B-BC0100XX</basicUdiDi>
    <tradeName>PEMPA KETO Glucose &amp; -Ketone Monitoring  System</tradeName>
    <deviceName>Blood glucose and β-ketone dual-monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020106019099</emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:23:21.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>A938795806</udiDi>
    <basicUdiDi>B-A938795806</basicUdiDi>
    <tradeName>EASYGLUCO Auto-coding Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>EASYGLUCO Auto-coding Blood Glucose Monitoring System for self-testing</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFM22AIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:11:56.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8800210900013UG</udiDi>
    <basicUdiDi>B-8800210900013UG</basicUdiDi>
    <tradeName>CareBuddy</tradeName>
    <deviceName>CareBuddy</deviceName>
    <manufacturerName>CareforU.Co.Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000031539</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGMB02</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:26:41.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSMgluketUV2EP</udiDi>
    <basicUdiDi>B-8012992BGMSMgluketUV2EP</basicUdiDi>
    <tradeName>GLUCOFIX TECH GK</tradeName>
    <deviceName>GLUCOFIX TECH GK Set</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020106019099</emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52076 FR/IT, 52077 FR-basic, 52078 NL, 56815 UK, 57170 FR-basic-E, 57168 FR, 57169 FR-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:06.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47546HU</udiDi>
    <basicUdiDi>B-47546HU</basicUdiDi>
    <tradeName>GLUCOCARD X-meter (GT-1910)</tradeName>
    <deviceName>GLUCOCARD X-meter (GT-1910)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>47546</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:07:30.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47536HR</udiDi>
    <basicUdiDi>B-47536HR</basicUdiDi>
    <tradeName>GLUCOCARD X-meter (GT-1910)</tradeName>
    <deviceName>GLUCOCARD X-meter (GT-1910)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>47536</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:07:29.383Z</lastUpdated>
  </row>
</eudamedExport>