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<eudamedExport entity="devices">
  <row>
    <udiDi>08800076701205</udiDi>
    <basicUdiDi>88000767HMCT001JN</basicUdiDi>
    <tradeName>08800076701205</tradeName>
    <deviceName>Hemonitor H1 Control Set</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMCT001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:34.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076701199</udiDi>
    <basicUdiDi>88000767HMAC050EN</basicUdiDi>
    <tradeName>Hemonitor H1 microcuvette</tradeName>
    <deviceName>Hemonitor H1 microcuvette</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503010203</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMAC050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:32.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076701007</udiDi>
    <basicUdiDi>88000767HMGA101G2</basicUdiDi>
    <tradeName>Hemonitor H1</tradeName>
    <deviceName>Hemonitor H1</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMGA101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:31.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076701328</udiDi>
    <basicUdiDi>88000767BGC0038K</basicUdiDi>
    <tradeName>ConfiGlu G1 Glucose Control solution 3</tradeName>
    <deviceName>ConfiGlu G1 Glucose Control Solution</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGC003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:24.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076701106</udiDi>
    <basicUdiDi>88000767BGC0028H</basicUdiDi>
    <tradeName>ConfiGlu G1 Glucose Control solution 2</tradeName>
    <deviceName>ConfiGlu G1 Glucose Control solution</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGC002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:23.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076700833</udiDi>
    <basicUdiDi>88000767BGMGS001PX</basicUdiDi>
    <tradeName>ConfiGlu G1 Blood Glucose Meter Set</tradeName>
    <deviceName>ConfiGlu G1 Blood Glucose Meter Set</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</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>BGMGS001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:17.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076700819</udiDi>
    <basicUdiDi>88000767BGSG001FP</basicUdiDi>
    <tradeName>ConfiGlu G1 Blood Glucose Test Strip</tradeName>
    <deviceName>ConfiGlu G1 Blood Glucose Test Strip</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGSG001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:16.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076700451</udiDi>
    <basicUdiDi>B-08800076700451</basicUdiDi>
    <tradeName>HelicoSign Dry</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HPYD050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:40.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076700918</udiDi>
    <basicUdiDi>B-08800076700918</basicUdiDi>
    <tradeName>GenBody KET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DKET010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:40.661Z</lastUpdated>
  </row>
</eudamedExport>