<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414473444</udiDi>
    <basicUdiDi>0405686900783W4</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i CSF Reagent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_CSF 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10320459</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:00.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414473413</udiDi>
    <basicUdiDi>0405686900800VB</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN2 Control)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in-1 Con Abnor 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10318905</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:00.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414473406</udiDi>
    <basicUdiDi>0405686900801VD</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN1 Control)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_TESTpt 3-in -1 Control Abnor 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10330063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:59.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414473390</udiDi>
    <basicUdiDi>0405686900799WK</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (Norm Control)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in -1 Con Normal</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10316217</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:55.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414224343</udiDi>
    <basicUdiDi>0405686900797WF</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i SETpoint Calibrator</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_SETpoint Calibrator</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10312285</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:39.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414224329</udiDi>
    <basicUdiDi>0405686900791W3</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i OPTIpoint</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_OPTIpoint</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10312283</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:34.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849832014003</udiDi>
    <basicUdiDi>849832011UJ</basicUdiDi>
    <tradeName>Scott’s Tap Water Substitute Working Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3802901E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:44.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849832019312</udiDi>
    <basicUdiDi>849832011UJ</basicUdiDi>
    <tradeName>SelecTech Blue Buffer 8 Ready-to-Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3802918</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:39.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698405148</udiDi>
    <basicUdiDi>697769840GKPD0926W</basicUdiDi>
    <tradeName>Diluent used for Hematology Analysis(HAS330)</tradeName>
    <deviceName>Diluent used for Hematology Analysis(HAS330)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD092</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:06.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698405087</udiDi>
    <basicUdiDi>697769840GKPD0916U</basicUdiDi>
    <tradeName>Lyse used for Hematology Analysis （Lyse）</tradeName>
    <deviceName>Lyse used for Hematology Analysis （Lyse）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD091</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:05.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698405032</udiDi>
    <basicUdiDi>697769840GKPD08979</basicUdiDi>
    <tradeName>Cleaner used for Hematology Analysis</tradeName>
    <deviceName>Cleaner used for Hematology Analysis</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD089</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:05.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404981</udiDi>
    <basicUdiDi>697769840GKPD08877</basicUdiDi>
    <tradeName>Lyse used for Hematology Analysis(LH)</tradeName>
    <deviceName>Lyse used for Hematology analysis（LH)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD088</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:04.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404936</udiDi>
    <basicUdiDi>697769840GKPD08775</basicUdiDi>
    <tradeName>Lyse used for Hematology Analysis（DIFF）</tradeName>
    <deviceName>Lyse used for Hematology Analysis（DIFF）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD087</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:00.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404929</udiDi>
    <basicUdiDi>697769840GKPD08673</basicUdiDi>
    <tradeName>Diluent used for Hematology Analysis</tradeName>
    <deviceName>Diluent used for Hematology Analysis</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD086</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T18:59:59.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978066777065</udiDi>
    <basicUdiDi>697806677HE001JV</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>6530-PA00002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:18.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978066777072</udiDi>
    <basicUdiDi>697806677HE001JV</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>6530-PA00003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:46:00.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978066778758</udiDi>
    <basicUdiDi>697806677SE001NN</basicUdiDi>
    <tradeName>Hematology Analyzer LYSE</tradeName>
    <deviceName>Hematology Analyzer LYSE</deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6520-PA00010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:10:21.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978066778765</udiDi>
    <basicUdiDi>697806677SE001NN</basicUdiDi>
    <tradeName>Hematology Analyzer LYSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6520-PA00005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:55:42.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849832012863</udiDi>
    <basicUdiDi>849832009UX</basicUdiDi>
    <tradeName>Aqueous Eosin 1%</tradeName>
    <deviceName>Eosin</deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3801590E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:48:00.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978066773586</udiDi>
    <basicUdiDi>697806677SE002NQ</basicUdiDi>
    <tradeName>Hematology Analyzer Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6600-PA00058</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:16.829Z</lastUpdated>
  </row>
</eudamedExport>