<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04033145179412</udiDi>
    <basicUdiDi>04033145CC18974FJ</basicUdiDi>
    <tradeName>Special Wash Solution</tradeName>
    <deviceName>Special Wash Solution</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18974</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:27:18.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145131250</udiDi>
    <basicUdiDi>04033145CC18973FG</basicUdiDi>
    <tradeName>Cuvette Clean</tradeName>
    <deviceName>Cuvette Clean</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16663/20</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:27:00.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145131243</udiDi>
    <basicUdiDi>04033145CC16663/25FE</basicUdiDi>
    <tradeName>Tip Cleaning Kit</tradeName>
    <deviceName>Tip Cleaning Kit</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16663/25</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:26:59.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145131229</udiDi>
    <basicUdiDi>04033145CC16663/10EZ</basicUdiDi>
    <tradeName>Diluent</tradeName>
    <deviceName>Diluent</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16663/10</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:26:58.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145118664</udiDi>
    <basicUdiDi>04033145CC18200DJ</basicUdiDi>
    <tradeName>HumaLyzer Primus</tradeName>
    <deviceName>HumaLyzer Primus</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18200</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:26:54.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145086802</udiDi>
    <basicUdiDi>04033145CC16930EG</basicUdiDi>
    <tradeName>HumaStar 300SR</tradeName>
    <deviceName>HumaStar 300SR</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16930</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:26:52.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145056546</udiDi>
    <basicUdiDi>04033145CC18971FC</basicUdiDi>
    <tradeName>Wash Additive</tradeName>
    <deviceName>Wash Additive</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18971</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:26:47.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145018773</udiDi>
    <basicUdiDi>04033145CC18222DU</basicUdiDi>
    <tradeName>Flow Cell Cleaner</tradeName>
    <deviceName>Flow Cell Cleaner</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18222</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:26:46.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>8053617720016ZF</udiDi>
    <basicUdiDi>B-8053617720016ZF</basicUdiDi>
    <tradeName>ITALO  M</tradeName>
    <deviceName>ITALO  M</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCIM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:58:32.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973947590092</udiDi>
    <basicUdiDi>6973947590092HC</basicUdiDi>
    <tradeName>VCHEMY S® EVO</tradeName>
    <deviceName>VCHEMY S® EVO</deviceName>
    <manufacturerName>Chengdu Seamaty Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033937</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVO-A01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:24.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048534000840</udiDi>
    <basicUdiDi>4048534AHAAVK</basicUdiDi>
    <tradeName>Cleaner</tradeName>
    <deviceName>Cleaner</deviceName>
    <manufacturerName>EKF-diagnostic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-6232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:56:51.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>14048534002742</udiDi>
    <basicUdiDi>4048534AHAAVK</basicUdiDi>
    <tradeName>Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKF-diagnostic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>3000-6233</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:48:59.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>24048534002749</udiDi>
    <basicUdiDi>4048534AHAAVK</basicUdiDi>
    <tradeName>Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKF-diagnostic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>3000-6235</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:48:58.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>05070002421337</udiDi>
    <basicUdiDi>50700024213ControlsZB</basicUdiDi>
    <tradeName>05070002421337</tradeName>
    <deviceName>Dxcover Control Pack</deviceName>
    <manufacturerName>Dxcover Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000046906</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DXC-CM-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:53:52.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414306179</udiDi>
    <basicUdiDi>0405686902189VY</basicUdiDi>
    <tradeName>Atellica HA1C_E High Volume Conversion Kit</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_HA1C_E HIGH VOLUME CONVERSION KIT</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>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11470732</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:54.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414304328</udiDi>
    <basicUdiDi>0405686902191VK</basicUdiDi>
    <tradeName>Atellica Lid Keying Feature</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_LID KEYING FEATURE KIT</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>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11597266</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:53.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414304311</udiDi>
    <basicUdiDi>0405686902192VM</basicUdiDi>
    <tradeName>Atellica HA1C_E High Volume Labels (50)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_HIGH VOLUME LABEL KIT</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>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11597090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:52.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414304304</udiDi>
    <basicUdiDi>0405686902190VH</basicUdiDi>
    <tradeName>Atellica HA1C_E High Volume Bottles (5)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_HIGH VOLUME BOTTLE KIT</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>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11597087</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:48.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768033124</udiDi>
    <basicUdiDi>0405686901028UY</basicUdiDi>
    <tradeName>Dimension CHK Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_CHK</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10481507</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:19:58.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768016356</udiDi>
    <basicUdiDi>0405686901042US</basicUdiDi>
    <tradeName>Dimension Vista Sample Probe Cleaner</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_Small Probe Cleaner</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:19:46.004Z</lastUpdated>
  </row>
</eudamedExport>