<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>D-ABT-OTH-A4604K</udiDi>
    <basicUdiDi>B-ABT-OTH-A4604K</basicUdiDi>
    <tradeName>Accu-Tell® Total Hardness Test</tradeName>
    <deviceName>Accu-Tell® Total Hardness Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-OTH-A460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:32.006Z</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-94H50TSCVQ</udiDi>
    <basicUdiDi>B-94H50TSCVQ</basicUdiDi>
    <tradeName>Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060601</emdnCode>
    <emdnDescription>CARBON DIOXIDE - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:58:04.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-94H50TXQ</udiDi>
    <basicUdiDi>B-94H50TXQ</basicUdiDi>
    <tradeName>Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060601</emdnCode>
    <emdnDescription>CARBON DIOXIDE - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94H50T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:58:02.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-94H100TAE</udiDi>
    <basicUdiDi>B-94H100TAE</basicUdiDi>
    <tradeName>Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060601</emdnCode>
    <emdnDescription>CARBON DIOXIDE - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94H100T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:58:00.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-94H100TSCA4</udiDi>
    <basicUdiDi>B-94H100TSCA4</basicUdiDi>
    <tradeName>Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060601</emdnCode>
    <emdnDescription>CARBON DIOXIDE - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94H100TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:57.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90102GS</udiDi>
    <basicUdiDi>B-90102GS</basicUdiDi>
    <tradeName>D-90102GS</tradeName>
    <deviceName>Vaginitis Multitest Kit（Enzyme Reaction）</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060401</emdnCode>
    <emdnDescription>MULTIPLE ENZYMES &amp;/OR SUBSTRATES &amp;/OR ELECTROLYTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:41.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90101-0272</udiDi>
    <basicUdiDi>B-90101-0272</basicUdiDi>
    <tradeName>D-90101-0272</tradeName>
    <deviceName>Vaginitis Multitest Kit（Enzyme Reaction）</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060401</emdnCode>
    <emdnDescription>MULTIPLE ENZYMES &amp;/OR SUBSTRATES &amp;/OR ELECTROLYTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:38.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90101-016Y</udiDi>
    <basicUdiDi>B-90101-016Y</basicUdiDi>
    <tradeName>D-90101-016Y</tradeName>
    <deviceName>Vaginitis Multitest Kit（Enzyme Reaction）</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060401</emdnCode>
    <emdnDescription>MULTIPLE ENZYMES &amp;/OR SUBSTRATES &amp;/OR ELECTROLYTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:37.258Z</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>80575028800131</udiDi>
    <basicUdiDi>B-80575028800131</basicUdiDi>
    <tradeName>80575028800131</tradeName>
    <deviceName>CLINI CHOL 10 TEST</deviceName>
    <manufacturerName>Callegari S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000035568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD19124P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:42:04.659Z</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>
</eudamedExport>