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    <basicUdiDi>0405686901007UQ</basicUdiDi>
    <tradeName>Dimension Vista® Aliquot Plates</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Aliquot Plates</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>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:51.438Z</lastUpdated>
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    <udiDi>00842768016257</udiDi>
    <basicUdiDi>0405686901045UY</basicUdiDi>
    <tradeName>Dimension Vista V-LYTE Dilution Check</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Dilution Check</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:48.262Z</lastUpdated>
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    <udiDi>00842768016240</udiDi>
    <basicUdiDi>0405686901044UW</basicUdiDi>
    <tradeName>Dimension Vista V-LYTE Diluent</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_V-LYTE 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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:48.246Z</lastUpdated>
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    <udiDi>00842768016028</udiDi>
    <basicUdiDi>0405686901077VD</basicUdiDi>
    <tradeName>Dimension CardioPhase high sensitivity CRP Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_CCRP</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444897</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:47.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768015656</udiDi>
    <basicUdiDi>0405686901013UK</basicUdiDi>
    <tradeName>Dimension Vista Empty Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Empty Flex reagent cartridge</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>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:45.579Z</lastUpdated>
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    <udiDi>00842768014321</udiDi>
    <basicUdiDi>0405686901188VP</basicUdiDi>
    <tradeName>Emit tox Serum Tricyclic Antidepressants Calibrator/Controls</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Serum TCA Calibrator/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>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445390</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:41.009Z</lastUpdated>
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  <row>
    <udiDi>00842768014314</udiDi>
    <basicUdiDi>0405686901187VM</basicUdiDi>
    <tradeName>Emit tox Serum Tricyclic Antidepressants Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Serum TCA 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>W0102090215</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445389</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:40.200Z</lastUpdated>
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    <udiDi>00842768014307</udiDi>
    <basicUdiDi>0405686901037UZ</basicUdiDi>
    <tradeName>Dimension QuikLYTE Flush Solution</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_QuikLYTE Flush Solution</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>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:39.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014277</udiDi>
    <basicUdiDi>0405686901027UW</basicUdiDi>
    <tradeName>Dimension® Chemistry Wash</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_Chem Wash</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:38.602Z</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>00842768014086</udiDi>
    <basicUdiDi>0405686901011UF</basicUdiDi>
    <tradeName>Dimension® Cuvette Cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Cuvette Cartridge</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:33.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014024</udiDi>
    <basicUdiDi>0405686901036UX</basicUdiDi>
    <tradeName>Dimension QuikLYTE Dilution Check</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_QuikLYTE Dilution Check</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>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444872</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:33.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014017</udiDi>
    <basicUdiDi>0405686901038V3</basicUdiDi>
    <tradeName>Dimension QuikLYTE Sample Diluent</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_QuikLYTE 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>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444874</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:32.196Z</lastUpdated>
  </row>
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    <udiDi>00842768013843</udiDi>
    <basicUdiDi>0405686901284VL</basicUdiDi>
    <tradeName>Dimension Myoglobin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_MYO</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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444907</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:28.400Z</lastUpdated>
  </row>
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    <udiDi>00842768013928</udiDi>
    <basicUdiDi>0405686901018UV</basicUdiDi>
    <tradeName>Dimension® Reaction Vessels</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_Reaction Vessels</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:28.371Z</lastUpdated>
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    <udiDi>00842768013874</udiDi>
    <basicUdiDi>0405686901314V4</basicUdiDi>
    <tradeName>Dimension Total Prostate Specific Antigen Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_TPSA</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>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444889</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:28.345Z</lastUpdated>
  </row>
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    <udiDi>00842768013829</udiDi>
    <basicUdiDi>0405686901279VT</basicUdiDi>
    <tradeName>Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Mass Creatine Kinase MB</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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444904</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:11.337Z</lastUpdated>
  </row>
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    <udiDi>00842768013782</udiDi>
    <basicUdiDi>0405686901032UP</basicUdiDi>
    <tradeName>Dimension® IMT Probe Cleaner</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_IMT Probe Cleaner</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>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:09.728Z</lastUpdated>
  </row>
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    <udiDi>00842768013775</udiDi>
    <basicUdiDi>0405686901041UQ</basicUdiDi>
    <tradeName>Dimension® Sample Probe Cleaner</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_Sample Probe Cleaner</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:08.930Z</lastUpdated>
  </row>
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    <udiDi>00842768013768</udiDi>
    <basicUdiDi>0405686901039V5</basicUdiDi>
    <tradeName>Dimension® Reagent Probe Cleaner</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_Reagent Probe Cleaner</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:07.332Z</lastUpdated>
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