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<eudamedExport entity="devices">
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    <basicUdiDi>0405686901186VK</basicUdiDi>
    <tradeName>Emit tox Serum Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Serum Calibrators</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>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:08.042Z</lastUpdated>
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  <row>
    <udiDi>00842768001116</udiDi>
    <basicUdiDi>0405686901222UW</basicUdiDi>
    <tradeName>Emit 2000 Vancomycin Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Vancomycin Calibrators</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445337</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:01.640Z</lastUpdated>
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  <row>
    <udiDi>00842768001079</udiDi>
    <basicUdiDi>0405686901204UU</basicUdiDi>
    <tradeName>Emit 2000 Tobramycin Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Tobramycin Calibrators</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445331</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:57.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001055</udiDi>
    <basicUdiDi>0405686901299VZ</basicUdiDi>
    <tradeName>Emit 2000 Quinidine Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Quinidine Calibrators</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:55.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001031</udiDi>
    <basicUdiDi>0405686901197VQ</basicUdiDi>
    <tradeName>Emit 2000 Theophylline Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Theophylline Calibrators</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445325</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:51.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001017</udiDi>
    <basicUdiDi>0405686901288VU</basicUdiDi>
    <tradeName>Emit 2000 N-Acetylprocainamide Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide Calibrators</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445322</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:48.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000997</udiDi>
    <basicUdiDi>0405686901294VP</basicUdiDi>
    <tradeName>Emit 2000 Procainamide Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Procainamide Calibrators</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445319</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:46.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000959</udiDi>
    <basicUdiDi>0405686901219V9</basicUdiDi>
    <tradeName>Emit 2000 Valproic Acid Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Valproic Acid Calibrators</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445313</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:44.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768037368</udiDi>
    <basicUdiDi>0405686900926W2</basicUdiDi>
    <tradeName>Dimension Vista PROT3 CAL</tradeName>
    <deviceName>IVDR_67_MAR EB_C_REAG_V_PROT3_CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10709555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:54.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768037344</udiDi>
    <basicUdiDi>0405686900889WM</basicUdiDi>
    <tradeName>N Protein Standard UY</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG_N_Prot_Stand_UY</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10709553</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:49.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768030215</udiDi>
    <basicUdiDi>0405686900922VS</basicUdiDi>
    <tradeName>Dimension Vista PROT1 CAL</tradeName>
    <deviceName>IVDR_67_MAR EB_C_REAG_V_PROT1_CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10469516</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:45.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768011528</udiDi>
    <basicUdiDi>0405686900956WB</basicUdiDi>
    <tradeName>N Apolipoprotein Standard Serum</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_Apo_Stand</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446465</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:17.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768011375</udiDi>
    <basicUdiDi>0405686900965WC</basicUdiDi>
    <tradeName>N Protein Standard PY</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG_N_Prot_Stand_PY</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446449</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:11.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768007224</udiDi>
    <basicUdiDi>0405686900888WK</basicUdiDi>
    <tradeName>N Lp(a) Standard SY</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_Lpa_Stand_SY</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:31.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768006463</udiDi>
    <basicUdiDi>0405686900924VW</basicUdiDi>
    <tradeName>Dimension Vista PROT2 CAL</tradeName>
    <deviceName>IVDR_67_MAR EB_C_REAG_V_PROT2_CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445935</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:03.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598000</udiDi>
    <basicUdiDi>0405686900812VJ</basicUdiDi>
    <tradeName>Atellica IM B‑Type Natriuretic Peptide Calibrator (BNP CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_BNP_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>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995473</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:48.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414555324</udiDi>
    <basicUdiDi>0405686900774W3</basicUdiDi>
    <tradeName>ADVIA Centaur Calibrator A (CAL A)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_CAL 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10285904</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:44.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414178493</udiDi>
    <basicUdiDi>0405686900814VN</basicUdiDi>
    <tradeName>ADVIA Centaur Calibrator U (Cal U)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_CAL U</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:12:50.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414168272</udiDi>
    <basicUdiDi>0405686900732VK</basicUdiDi>
    <tradeName>Emit 2000 Mycophenolic Acid Calibrators</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Mycophenolic Acid_Cal</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10730959</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:12:48.423Z</lastUpdated>
  </row>
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    <udiDi>00842768035432</udiDi>
    <basicUdiDi>0405686900215US</basicUdiDi>
    <tradeName>Dimension Tacrolimus Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_TAC_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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10700796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:48.428Z</lastUpdated>
  </row>
</eudamedExport>