<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00842768016332</udiDi>
    <basicUdiDi>0405686901030UK</basicUdiDi>
    <tradeName>Dimension Vista Cuvette Wash Solution</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_Cuvette Wash Solution</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>10445207</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:19:45.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595474</udiDi>
    <basicUdiDi>0405686901591VY</basicUdiDi>
    <tradeName>ADVIA Chemistry XPT Cuvette Detergent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_XPT Cuvette Detergent</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>10718753</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:10:59.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145179382</udiDi>
    <basicUdiDi>04033145CC18973FG</basicUdiDi>
    <tradeName>Cuvette Clean</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18973</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T06:26:46.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768016349</udiDi>
    <basicUdiDi>0405686901039V5</basicUdiDi>
    <tradeName>Dimension Vista Reagent Probe Cleaner</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_Reagent 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>10445208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:26.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595504</udiDi>
    <basicUdiDi>0405686901592W2</basicUdiDi>
    <tradeName>ADVIA Chemistry XPT Probe Wash 0</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_XPT Probe Wash 0</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>10718756</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:42.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600717621045</udiDi>
    <basicUdiDi>5600717621CARTDRIGE94</basicUdiDi>
    <tradeName>05600717621045</tradeName>
    <deviceName>Labinlight Cartdrige</deviceName>
    <manufacturerName>LABINLIGHT, LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000034199</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>H100100</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:01:39.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>04902520282798</udiDi>
    <basicUdiDi>454741030100000000000436U</basicUdiDi>
    <tradeName>FUJI PLAIN TUBE</tradeName>
    <deviceName>FUJI PLAIN TUBE</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04902520282798</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:53.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>04902520282767</udiDi>
    <basicUdiDi>454741030100000000000426S</basicUdiDi>
    <tradeName>FUJI HEPARIN TUBE</tradeName>
    <deviceName>FUJI HEPARIN TUBE</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04902520282767</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:52.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04902520282620</udiDi>
    <basicUdiDi>4547410301000000000003975</basicUdiDi>
    <tradeName>FUJI DRI-CHEM MIXING CUPS S</tradeName>
    <deviceName>FUJI DRI-CHEM MIXING CUPS</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04902520282620</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:51.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768024719</udiDi>
    <basicUdiDi>0405686901009UU</basicUdiDi>
    <tradeName>Dimension Vista Barcode Labels</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Barcode Labels</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>10464353</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:40.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768016295</udiDi>
    <basicUdiDi>0405686901014UM</basicUdiDi>
    <tradeName>Dimension Vista® Empty Vials Kit</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Empty Vials Kit</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>10445213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:54.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768016271</udiDi>
    <basicUdiDi>0405686901010UD</basicUdiDi>
    <tradeName>Dimension Vista Cuvettes (CUV)</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_CUV</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>10445211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:54.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768016264</udiDi>
    <basicUdiDi>0405686901007UQ</basicUdiDi>
    <tradeName>Dimension Vista® Aliquot Plates</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Aliquot Plates</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>10445210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:51.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768015656</udiDi>
    <basicUdiDi>0405686901013UK</basicUdiDi>
    <tradeName>Dimension Vista Empty Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Empty Flex reagent cartridge</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>10445218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:45.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768004865</udiDi>
    <basicUdiDi>0405686901008US</basicUdiDi>
    <tradeName>Dimension® Aliquot Wheel Assembly</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Aliquot Wheel Assembly</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>10445043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:44.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596532</udiDi>
    <basicUdiDi>0405686901578W8</basicUdiDi>
    <tradeName>Atellica CH Reagent Probe Cleaner 2 (RPC2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Cleaner 2</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>11099313</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:27.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596556</udiDi>
    <basicUdiDi>0405686901548VX</basicUdiDi>
    <tradeName>Atellica CH Check Reagent (CHK)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Check Reagent</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>11099311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:26.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596549</udiDi>
    <basicUdiDi>0405686901577W6</basicUdiDi>
    <tradeName>Atellica CH Reagent Probe Cleaner 1 (RPC1)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Cleaner 1</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>11099312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:25.889Z</lastUpdated>
  </row>
</eudamedExport>