<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08592156188944</udiDi>
    <basicUdiDi>8592156CCIN0058SW</basicUdiDi>
    <tradeName>Chem 5 v3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00013</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:29:18.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156098977</udiDi>
    <basicUdiDi>8592156CCIN0056SS</basicUdiDi>
    <tradeName>CHEM-7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00014</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:29:07.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596143</udiDi>
    <basicUdiDi>0405686901524VH</basicUdiDi>
    <tradeName>Atellica CH Reaction Cuvette Segment</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_INST_Reaction Cuvette Segment</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099326</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:26.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOBPLUR-AVJ</udiDi>
    <basicUdiDi>B-MOBPLUR-AVJ</basicUdiDi>
    <tradeName>URA - CLINICAL CHEMISTRY ANALYZER</tradeName>
    <deviceName>Clinical Chemistry Analyzer</deviceName>
    <manufacturerName>Medsource Ozone Biomedicals Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000042128</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>UR-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:08:56.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOBPLEC9005PD</udiDi>
    <basicUdiDi>B-MOBPLEC9005PD</basicUdiDi>
    <tradeName>URA PREMIO - CLINICAL CHEMISTRY ANALYZER</tradeName>
    <deviceName>Clinical Chemistry Analyzer</deviceName>
    <manufacturerName>Medsource Ozone Biomedicals Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000042128</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EC9005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:08:55.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HYDRA09PLUSTD</udiDi>
    <basicUdiDi>B-HYDRA09PLUSTD</basicUdiDi>
    <tradeName>D-HYDRA09PLUSTD</tradeName>
    <deviceName>Hydra 09 Plus</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NHY09</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:44.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664017</udiDi>
    <basicUdiDi>B-08806134664017</basicUdiDi>
    <tradeName>08806134664017</tradeName>
    <deviceName>GCare Lipid</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCM110M10</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:48.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065158201</udiDi>
    <basicUdiDi>B-08800065158201</basicUdiDi>
    <tradeName>CERA-CHEK™ Lactate Measuring System</tradeName>
    <deviceName>Lactate Measuring System</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L400M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:13.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700860266</udiDi>
    <basicUdiDi>37017008Microlab-seriesHC</basicUdiDi>
    <tradeName>Microlab 300LX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-075</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402712748</udiDi>
    <basicUdiDi>B-07640402712748</basicUdiDi>
    <tradeName>FORA 6 Duo Multifunkční monitorovací systém</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:55.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402712250</udiDi>
    <basicUdiDi>B-07640402712250</basicUdiDi>
    <tradeName>FORA 6 Connect</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:37.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402712243</udiDi>
    <basicUdiDi>B-07640402712243</basicUdiDi>
    <tradeName>FORA 6 Connect</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:36.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402712236</udiDi>
    <basicUdiDi>B-07640402712236</basicUdiDi>
    <tradeName>FORA 6 Connect</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:35.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402711840</udiDi>
    <basicUdiDi>B-07640402711840</basicUdiDi>
    <tradeName>FORA 6 Connect</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:30.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402711734</udiDi>
    <basicUdiDi>B-07640402711734</basicUdiDi>
    <tradeName>FORA 6 Duo Multi-Functional Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:29.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402711345</udiDi>
    <basicUdiDi>B-07640402711345</basicUdiDi>
    <tradeName>FORA 6 Connect</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:26.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402711284</udiDi>
    <basicUdiDi>B-07640402711284</basicUdiDi>
    <tradeName>FORA 6 Connect</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:25.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640402710904</udiDi>
    <basicUdiDi>B-07640402710904</basicUdiDi>
    <tradeName>FORA 6 Duo Multi-Functional Monitoring System</tradeName>
    <deviceName>Multi functional Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:18.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640143659302</udiDi>
    <basicUdiDi>B-07640143659302</basicUdiDi>
    <tradeName>FORA 6 Connect Multi-Functional Monitoring System</tradeName>
    <deviceName>Multi-Functional Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:58:07.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640143658930</udiDi>
    <basicUdiDi>B-07640143658930</basicUdiDi>
    <tradeName>FORA 6 Connect Multi-Functional Monitoring System</tradeName>
    <deviceName>FORA 6 Connect Multi-Functional Monitoring System</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:58:02.591Z</lastUpdated>
  </row>
</eudamedExport>