<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-BK1-10M-2AD</udiDi>
    <basicUdiDi>B-BK1-10M-2AD</basicUdiDi>
    <tradeName>BeneCheck Multi-Monitoring System</tradeName>
    <deviceName>Blood glucose, uric acid, and total cholesterol multi-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>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK1-10M-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:59.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK1-10M-1AB</udiDi>
    <basicUdiDi>B-BK1-10M-1AB</basicUdiDi>
    <tradeName>BeneCheck Multi-Monitoring System</tradeName>
    <deviceName>Blood glucose, uric acid, and total cholesterol multi-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>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK1-10M-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:58.767Z</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-48303H7</udiDi>
    <basicUdiDi>B-48303H7</basicUdiDi>
    <tradeName>Lactate Pro 2 (LT-1730)</tradeName>
    <deviceName>Lactate Pro 2 (LT-1730)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069080</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:32.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-48302H5</udiDi>
    <basicUdiDi>B-48302H5</basicUdiDi>
    <tradeName>Lactate Pro 2 (LT-1730)</tradeName>
    <deviceName>Lactate Pro 2 (LT-1730)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069080</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48302</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:30.292Z</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>
  <row>
    <udiDi>D-47396HZ</udiDi>
    <basicUdiDi>B-47396HZ</basicUdiDi>
    <tradeName>GLUCOCARD SM (GT-7120)</tradeName>
    <deviceName>GLUCOCARD SM (GT-7120)</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>47396</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:05.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-471987421AP-10METER8SJN</udiDi>
    <basicUdiDi>B-471987421AP-10METER8SJN</basicUdiDi>
    <tradeName>AP-10</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Leison Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000026417</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:28.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487609BU94</udiDi>
    <basicUdiDi>B-47136487609BU94</basicUdiDi>
    <tradeName>KETOSURE POC</tradeName>
    <deviceName>KETOSURE POC base unit</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069080</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5400044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:26.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487603C367</udiDi>
    <basicUdiDi>B-47136487603C367</basicUdiDi>
    <tradeName>Wellion AMADEUS</tradeName>
    <deviceName>Wellion AMADEUS Set</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</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>S70522, S70523</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:39.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487600B05F</udiDi>
    <basicUdiDi>B-47136487600B05F</basicUdiDi>
    <tradeName>Eclipse A1C</tradeName>
    <deviceName>Eclipse A1C Hemoglobin A1c POC analyzer</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S54133, S54144, S54145, S54119</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:09.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46907HX</udiDi>
    <basicUdiDi>B-46907HX</basicUdiDi>
    <tradeName>GLUCOCARD Vital (GT-1050)</tradeName>
    <deviceName>GLUCOCARD Vital (GT-1050)</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>46907</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:12.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050108VFEQ</udiDi>
    <basicUdiDi>B-4680008050108VFEQ</basicUdiDi>
    <tradeName>HELIC ABT Suction pump</tradeName>
    <deviceName>HELIC Ammonia Breath Test (HELIC ABT Suction pump)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069080</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0108</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:42.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46748J3</udiDi>
    <basicUdiDi>B-46748J3</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</tradeName>
    <deviceName>GLUCOCARD X-mini plus (GT-1960)</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>46748</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:09.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46746HX</udiDi>
    <basicUdiDi>B-46746HX</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</tradeName>
    <deviceName>GLUCOCARD X-mini plus (GT-1960)</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>46746</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:06.601Z</lastUpdated>
  </row>
</eudamedExport>