<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-BK-CSG409M</udiDi>
    <basicUdiDi>B-BK-CSG409M</basicUdiDi>
    <tradeName>BeneCheck III Glucose Control Solution</tradeName>
    <deviceName>Glucose control solution</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSG40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:13.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-CSG329N</udiDi>
    <basicUdiDi>B-BK-CSG329N</basicUdiDi>
    <tradeName>BeneCheck II Glucose Control Solution</tradeName>
    <deviceName>Glucose control solution</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSG32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:12.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-CSG319L</udiDi>
    <basicUdiDi>B-BK-CSG319L</basicUdiDi>
    <tradeName>BeneCheck II Glucose Control Solution</tradeName>
    <deviceName>Glucose control solution</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSG31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:12.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-CSG309J</udiDi>
    <basicUdiDi>B-BK-CSG309J</basicUdiDi>
    <tradeName>BeneCheck II Glucose Control Solution</tradeName>
    <deviceName>Glucose control solution</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSG30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:08.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-CSC228X</udiDi>
    <basicUdiDi>B-BK-CSC228X</basicUdiDi>
    <tradeName>BeneCheck II Total Cholesterol Control Solution</tradeName>
    <deviceName>Total cholesterol control solution</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSC22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:06.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-CSC218V</udiDi>
    <basicUdiDi>B-BK-CSC218V</basicUdiDi>
    <tradeName>BeneCheck II Total Cholesterol Control Solution</tradeName>
    <deviceName>Total cholesterol control solution</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSC21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:05.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-C2SA</udiDi>
    <basicUdiDi>B-BK-C2SA</basicUdiDi>
    <tradeName>BeneCheck Total Cholesterol Test Strip</tradeName>
    <deviceName>Total Cholesterol Test Strip</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-C2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:04.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-C1S8</udiDi>
    <basicUdiDi>B-BK-C1S8</basicUdiDi>
    <tradeName>BeneCheck Total Cholesterol Test Strip</tradeName>
    <deviceName>Total Cholesterol Test Strip</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BK-C1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:58.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>A938796036</udiDi>
    <basicUdiDi>B-A938796036</basicUdiDi>
    <tradeName>EASYGLUCO Auto-coding Blood Glucose Test Strip</tradeName>
    <deviceName>EASYGLUCO Auto-coding Blood Glucose Test Strip</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFS22AIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:11:58.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>A938795921</udiDi>
    <basicUdiDi>B-A938795921</basicUdiDi>
    <tradeName>EASYGLUCO Auto-coding Blood Glucose Test Strip</tradeName>
    <deviceName>EASYGLUCO Auto-coding Blood Glucose Test Strip</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFSS22AIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:11:57.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8800210900068V9</udiDi>
    <basicUdiDi>B-8800210900068V9</basicUdiDi>
    <tradeName>HUBI A1c</tradeName>
    <deviceName>HUBI DIA</deviceName>
    <manufacturerName>CareforU.Co.Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000031539</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHA1C-8010</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:26:45.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8800210900037UW</udiDi>
    <basicUdiDi>B-8800210900037UW</basicUdiDi>
    <tradeName>CareBuddy HbA1c</tradeName>
    <deviceName>CareBuddy Multi</deviceName>
    <manufacturerName>CareforU.Co.Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000031539</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDC1B02</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:26:45.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8800210900006UK</udiDi>
    <basicUdiDi>B-8800210900006UK</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGSB02</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:26:40.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSSketEFRL</udiDi>
    <basicUdiDi>B-8012992BGMSSketEFRL</basicUdiDi>
    <tradeName>GlucoMen areo B-Ketone Sensor</tradeName>
    <deviceName>GlucoMen areo B-Ketone Sensor</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48106,48105,49245,48103,48688,48101,47953,47951,47952,48703,48820,48821,48530,48531</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:15.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSSketEF2KQ</udiDi>
    <basicUdiDi>B-8012992BGMSSketEF2KQ</basicUdiDi>
    <tradeName>GLUCOFIX TECH  B-Ketone Sensor</tradeName>
    <deviceName>GLUCOFIX TECH  B-Ketone Sensor</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>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48726 NL, 49911 FR, 50404 FR-E, 50415 FR, 48583 IT,  57171 UK-IT-FR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:13.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSSgluEJS6</udiDi>
    <basicUdiDi>B-8012992BGMSSgluEJS6</basicUdiDi>
    <tradeName>GlucoMen areo Sensor</tradeName>
    <deviceName>GlucoMen areo Sensor</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46182,46181,46184,46183,46192,46193,46191,46190,46189,46188,47948,48702,48704,48705,48706,48526, 48527,48528,48529,49198</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:11.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSSgluEJ2M4</udiDi>
    <basicUdiDi>B-8012992BGMSSgluEJ2M4</basicUdiDi>
    <tradeName>GLUCOFIX TECH Sensor</tradeName>
    <deviceName>GLUCOFIX TECH Sensor</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46627 NL, 46626, 46623 FR, 46622 FR10,47688 FR 50, 48587 IT, 48586 IT10, 48585 IT25, 48584 IT, 51342 UK, 51343 UK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:10.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSMgluketUVRW</udiDi>
    <basicUdiDi>B-8012992BGMSMgluketUVRW</basicUdiDi>
    <tradeName>GlucoMen areo GK</tradeName>
    <deviceName>GlucoMen areo GK</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54524, 52082, 52081, 52083, 61554, 61553,</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:09.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSMgluD8NK</udiDi>
    <basicUdiDi>B-8012992BGMSMgluD8NK</basicUdiDi>
    <tradeName>GlucoMen areo</tradeName>
    <deviceName>GlucoMen areo 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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46203, 46211,46210, 46213, 49261, 48742, 46214, 46215, 46212</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:05.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSMgluD82G6</udiDi>
    <basicUdiDi>B-8012992BGMSMgluD82G6</basicUdiDi>
    <tradeName>GLUCOFIX TECH</tradeName>
    <deviceName>GLUCOFIX TECH</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46639 , 46634,  46635, 46636, 46637,  49573,  51344</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:04.998Z</lastUpdated>
  </row>
</eudamedExport>