<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987595300820</udiDi>
    <basicUdiDi>4987595PATHFASTSC</basicUdiDi>
    <tradeName>PATHFAST</tradeName>
    <deviceName>PATHFAST</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</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>300820</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:06.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486044604</udiDi>
    <basicUdiDi>4987486BC0109504H6</basicUdiDi>
    <tradeName>WeCheck for S onyx</tradeName>
    <deviceName>WeCheck for S onyx</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020106019082</emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109504</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:57.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713648764581</udiDi>
    <basicUdiDi>47136487607B00KBUa79</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069080</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:29:58.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713648764574</udiDi>
    <basicUdiDi>47136487607B00KMbYP</basicUdiDi>
    <tradeName>KETOSURE POC</tradeName>
    <deviceName>KETOSURE POC Blood Ketone Monitoring System</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020106019099</emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:29:45.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713648762198</udiDi>
    <basicUdiDi>47136487606B00MCSa73</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS Multi-Purpose Analyzer</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:29:44.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560189238787</udiDi>
    <basicUdiDi>45601892100040027H</basicUdiDi>
    <tradeName>90 Sample Loader 	G8-90SL</tradeName>
    <deviceName>Tosoh Automated Glycohemoglobin Analyzer HLC-723G8</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020106019080</emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0021561</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:48.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262560810017</udiDi>
    <basicUdiDi>426256081DBASE46</basicUdiDi>
    <tradeName>D-Base 2.0</tradeName>
    <deviceName>D-Base 2.0</deviceName>
    <manufacturerName>DiaMonTech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006344</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>10012004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:43:39.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260497270607</udiDi>
    <basicUdiDi>42604972700022MW</basicUdiDi>
    <tradeName>BLOTrix System 5/ BLOTrix Reader C1 L</tradeName>
    <deviceName>BLOTrix System 5</deviceName>
    <manufacturerName>BioSciTec GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007888</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069080</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>b55btrc1l</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:02:44.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260497270553</udiDi>
    <basicUdiDi>42604972700021MU</basicUdiDi>
    <tradeName>04260497270553</tradeName>
    <deviceName>BLOTrix System 4</deviceName>
    <manufacturerName>BioSciTec GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007888</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069080</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>b4c4btrc1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:02:42.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260497270225</udiDi>
    <basicUdiDi>42604972700005MW</basicUdiDi>
    <tradeName>JAEGER mobile Reader</tradeName>
    <deviceName>JAEGER mobile Reader</deviceName>
    <manufacturerName>BioSciTec GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007888</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069080</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JmR-mB2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:02:40.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128310661</udiDi>
    <basicUdiDi>88061283AGM2100MDV</basicUdiDi>
    <tradeName>trister® Blood Glucose Test Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2100-M2-P1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:46.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128310685</udiDi>
    <basicUdiDi>88061283AGM2100KDR</basicUdiDi>
    <tradeName>trister® Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2100-K2-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:46.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128340460</udiDi>
    <basicUdiDi>88061283AGM4000MEC</basicUdiDi>
    <tradeName>G1 Advance Blood Glucose Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-4000-M2-P1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128340484</udiDi>
    <basicUdiDi>88061283AGM4000KE8</basicUdiDi>
    <tradeName>G1 Advance Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-4000-K2-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128340866</udiDi>
    <basicUdiDi>88061283AGM4000MEC</basicUdiDi>
    <tradeName>GlucoSmart® Swing2 Blood Glucose Test Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-4000-M3-P1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128340880</udiDi>
    <basicUdiDi>88061283AGM4000KE8</basicUdiDi>
    <tradeName>GlucoSmart® Swing2 Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-4000-K3-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128351060</udiDi>
    <basicUdiDi>88061283AGM513SMJK</basicUdiDi>
    <tradeName>familyDr.™ Blood Glucose Test Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-513S-M2-P1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128351084</udiDi>
    <basicUdiDi>88061283AGM513SKJF</basicUdiDi>
    <tradeName>familyDr.™ Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-513S-K2-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128351169</udiDi>
    <basicUdiDi>88061283ABM513SMFW</basicUdiDi>
    <tradeName>familyDr.™ BLE Blood Glucose Test Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABM-513S-M2-P1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:44.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806128351183</udiDi>
    <basicUdiDi>88061283ABM513SKFS</basicUdiDi>
    <tradeName>familyDr.™ BLE Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABM-513S-K2-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:44.970Z</lastUpdated>
  </row>
</eudamedExport>