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<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00840733103285</udiDi>
    <basicUdiDi>008407331REVOGENECLA002TH</basicUdiDi>
    <tradeName>Revogene® Check</tradeName>
    <deviceName>Revogene® Check</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000010460</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:25:28.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>13125620.01.0001011</udiDi>
    <basicUdiDi>PP12562CALLOESUNG20</basicUdiDi>
    <tradeName>13125620.01.0001011</tradeName>
    <deviceName>Solution</deviceName>
    <manufacturerName>Axel Löser Messtechnik</manufacturerName>
    <manufacturerSrn>DE-MF-000023401</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.01.0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:41:08.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URINARY-PROTEINS-CtrlFR</udiDi>
    <basicUdiDi>B-URINARY-PROTEINS-CtrlFR</basicUdiDi>
    <tradeName>URINARY PROTEINS CONTROL</tradeName>
    <deviceName>URINARY PROTEINS CONTROL</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC50-3-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:26.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U172053W</udiDi>
    <basicUdiDi>B-U172053W</basicUdiDi>
    <tradeName>D-U172053W</tradeName>
    <deviceName>ISE Calibrator Low</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U17205</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:27:28.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U172063Y</udiDi>
    <basicUdiDi>B-U172063Y</basicUdiDi>
    <tradeName>D-U172063Y</tradeName>
    <deviceName>ISE Calibrator High</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U17206</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:27:25.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SL-SCA-SPDY</udiDi>
    <basicUdiDi>B-SL-SCA-SPDY</basicUdiDi>
    <tradeName>D-SL-SCA-SPDY</tradeName>
    <deviceName>Serum protein control abnormal</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-SCA-SP</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:44.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SL-SC-SPP4</udiDi>
    <basicUdiDi>B-SL-SC-SPP4</basicUdiDi>
    <tradeName>D-SL-SC-SPP4</tradeName>
    <deviceName>Serum protein control normal</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-SC-SP</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:40.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCRSV-SDK</udiDi>
    <basicUdiDi>B-SCRSV-SDK</basicUdiDi>
    <tradeName>D-SCRSV-SDK</tradeName>
    <deviceName>RSV Control</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCRSV-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:30.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCROT-D-LTJ</udiDi>
    <basicUdiDi>B-SCROT-D-LTJ</basicUdiDi>
    <tradeName>D-SCROT-D-LTJ</tradeName>
    <deviceName>Rotavirus Control</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCROT-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:24.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCNOR-D-LQQ</udiDi>
    <basicUdiDi>B-SCNOR-D-LQQ</basicUdiDi>
    <tradeName>D-SCNOR-D-LQQ</tradeName>
    <deviceName>Norovirus Control</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCNOR-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:08.595Z</lastUpdated>
  </row>
</eudamedExport>