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<eudamedExport entity="devices">
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    <udiDi>00842768000942</udiDi>
    <basicUdiDi>0405686901218V7</basicUdiDi>
    <tradeName>Emit 2000 Valproic Acid Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Valproic Acid Assay</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>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:42.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000133</udiDi>
    <basicUdiDi>0405686901148VB</basicUdiDi>
    <tradeName>Emit II Plus Methadone Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Methadone Assay</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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445426</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:39.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000119</udiDi>
    <basicUdiDi>0405686901040UN</basicUdiDi>
    <tradeName>Dimension® Sample Diluent</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_Sample Diluent</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>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444875</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:39.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000096</udiDi>
    <basicUdiDi>0405686901035UV</basicUdiDi>
    <tradeName>Dimension® Purified Water Diluent</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_Purified Water Diluent</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>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444887</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:36.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414594484</udiDi>
    <basicUdiDi>0405686901164V9</basicUdiDi>
    <tradeName>Dimension Phosphorus Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_PHOS</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>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720277</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:55.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414593579</udiDi>
    <basicUdiDi>0405686901015UP</basicUdiDi>
    <tradeName>Dimension® EXL™ 200 Integrated Chemistry System</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_EXL 200 integrated chemistry system</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>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10636929</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:54.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414229591</udiDi>
    <basicUdiDi>0405686901052UV</basicUdiDi>
    <tradeName>Emit II Plus 6-Acetylmorphine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_6-Acetylmorphine Assay</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>W0102090116</emdnCode>
    <emdnDescription>6-ACETHYLMORPHIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10730975</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:21.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414028019</udiDi>
    <basicUdiDi>0405686901153V4</basicUdiDi>
    <tradeName>Emit II Plus Oxycodone Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Assay</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>W0102090123</emdnCode>
    <emdnDescription>OXYCODINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720808</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:22:31.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414027975</udiDi>
    <basicUdiDi>0405686901154V6</basicUdiDi>
    <tradeName>Emit II Plus Oxycodone Positive Control 300</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Pos and Neg Controls</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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720812</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:22:30.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768037726</udiDi>
    <basicUdiDi>0405686900216UU</basicUdiDi>
    <tradeName>Dimension EXL LOCI High Sensitivity Troponin I Flex Reagent Cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_TNIH</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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10471068</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:53.696Z</lastUpdated>
  </row>
  <row>
    <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>
  <row>
    <udiDi>00842768035425</udiDi>
    <basicUdiDi>0405686900214UQ</basicUdiDi>
    <tradeName>Dimension Tacrolimus Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_TAC</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>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10700795</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:47.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023231</udiDi>
    <basicUdiDi>0405686900203UK</basicUdiDi>
    <tradeName>Emit® 2000 Carbamazepine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Carbamazepine Assay</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:42.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023361</udiDi>
    <basicUdiDi>0405686900202UH</basicUdiDi>
    <tradeName>Emit® II Plus Amphetamines Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Amphetamines Assay</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>W0102090101</emdnCode>
    <emdnDescription>AMPHETAMINES GROUP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445419</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:40.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005725</udiDi>
    <basicUdiDi>0405686900205UP</basicUdiDi>
    <tradeName>Dimension Prealbumin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_PALB</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444978</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:52.254Z</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>00842768001512</udiDi>
    <basicUdiDi>0405686900213UN</basicUdiDi>
    <tradeName>Emit 2000 Mycophenolic Acid Controls</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid controls</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>10445381</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:49.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001505</udiDi>
    <basicUdiDi>0405686900212UL</basicUdiDi>
    <tradeName>Emit 2000 Mycophenolic Acid Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic 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>10445380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:47.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001499</udiDi>
    <basicUdiDi>0405686900211UJ</basicUdiDi>
    <tradeName>Emit 2000 Mycophenolic Acid Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid Assay</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>W0102080605</emdnCode>
    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445379</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:45.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414976624</udiDi>
    <basicUdiDi>0405686900207UT</basicUdiDi>
    <tradeName>Dimension EXL LOCI Vitamin B12 Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_VB12</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10463371</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:04:43.834Z</lastUpdated>
  </row>
</eudamedExport>