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<eudamedExport entity="devices">
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    <udiDi>00811403010332</udiDi>
    <basicUdiDi>081140301CD4787014DJH</basicUdiDi>
    <tradeName>Fluid pack</tradeName>
    <deviceName>CONDITONER, FLUIDS PACK</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-478701-4D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:06.292Z</lastUpdated>
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  <row>
    <udiDi>00811403010318</udiDi>
    <basicUdiDi>081140301CD104227ADC6</basicUdiDi>
    <tradeName>Calibration solution</tradeName>
    <deviceName>348 Cal-Pack</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-104227AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:04.495Z</lastUpdated>
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    <udiDi>00811403010172</udiDi>
    <basicUdiDi>081140301AVBP0442D3Z</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Standard B AW</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV-BP0442D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:53.483Z</lastUpdated>
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  <row>
    <udiDi>00811403010141</udiDi>
    <basicUdiDi>081140301AVBP0380D48</basicUdiDi>
    <tradeName>Conditioning solution</tradeName>
    <deviceName>Electrode Conditioning Solution</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV-BP0380D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:51.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403010035</udiDi>
    <basicUdiDi>081140301AVBP0095D47</basicUdiDi>
    <tradeName>Reference solution</tradeName>
    <deviceName>Reference Solution AW</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV-BP0095D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:35.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414636672</udiDi>
    <basicUdiDi>0405686902246VK</basicUdiDi>
    <tradeName>Atellica CH Protein 1 Calibrator (PROT1 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PROT 1 CAL</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:35.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414615097</udiDi>
    <basicUdiDi>0405686902241V9</basicUdiDi>
    <tradeName>Atellica CH Bilirubin Calibrator (BILI CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_BILI CAL</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:44.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597492</udiDi>
    <basicUdiDi>0405686901837W9</basicUdiDi>
    <tradeName>Atellica CH Chemistry Calibrator (CHEM CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Chemistry 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:47.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597225</udiDi>
    <basicUdiDi>0405686901704VM</basicUdiDi>
    <tradeName>Atellica CH ENZ 1 Calibrator (ENZ 1 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ENZ 1 CAL</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099317</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:44.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597249</udiDi>
    <basicUdiDi>0405686901706VR</basicUdiDi>
    <tradeName>Atellica CH ENZ 3 Calibrator (ENZ 3 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_ENZ 3 CAL</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099319</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:44.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414279190</udiDi>
    <basicUdiDi>0405686901793WE</basicUdiDi>
    <tradeName>Atellica CH Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_UCFP CAL</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099339</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:40.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014093</udiDi>
    <basicUdiDi>0405686901058V9</basicUdiDi>
    <tradeName>Dimension® ALDL Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_ALDL CAL</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:34.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005206</udiDi>
    <basicUdiDi>0405686901123UT</basicUdiDi>
    <tradeName>Dimension Total Iron Binding Capacity (IBCT) Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_IBCT CAL</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:49.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005190</udiDi>
    <basicUdiDi>0405686901189VR</basicUdiDi>
    <tradeName>Dimension® Special Protein Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_SP CAL</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:48.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597379</udiDi>
    <basicUdiDi>0405686900777W9</basicUdiDi>
    <tradeName>Atellica CH CHEM III Calibrator (CHEM III CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_CHEM III_Cal</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099335</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:41.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597218</udiDi>
    <basicUdiDi>0405686900762VU</basicUdiDi>
    <tradeName>Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ALP_2_Cal</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099316</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:39.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597201</udiDi>
    <basicUdiDi>0405686900761VS</basicUdiDi>
    <tradeName>Atellica CH Albumin BCP Calibrator (AlbP CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ALBP_Cal</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:37.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595740</udiDi>
    <basicUdiDi>0405686900823VP</basicUdiDi>
    <tradeName>Atellica CH A‑LYTE IMT Standard A</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_IMT Standard A</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099304</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:04.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595719</udiDi>
    <basicUdiDi>0405686900824VR</basicUdiDi>
    <tradeName>Atellica CH A‑LYTE IMT Standard B + Salt Bridge</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_IMT Standard B + Salt Bridge</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:02.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005183</udiDi>
    <basicUdiDi>0405686900206UR</basicUdiDi>
    <tradeName>Dimension Prealbumin Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_PALB_cal</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:49.847Z</lastUpdated>
  </row>
</eudamedExport>