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<eudamedExport entity="devices">
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    <basicUdiDi>0405686900738VX</basicUdiDi>
    <tradeName>Atellica CH A-LYTE IMT Dilution Check</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_IMT Dilution Check</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099325</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:27.522Z</lastUpdated>
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    <udiDi>00630414595887</udiDi>
    <basicUdiDi>0405686900832VQ</basicUdiDi>
    <tradeName>Atellica CH Salicylate (Sal)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_SAL</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>W0102090213</emdnCode>
    <emdnDescription>SALICYLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097523</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:24.822Z</lastUpdated>
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  <row>
    <udiDi>00630414595986</udiDi>
    <basicUdiDi>0405686900775W5</basicUdiDi>
    <tradeName>Atellica CH Carbamazepine (Carb)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Carb</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:23.257Z</lastUpdated>
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  <row>
    <udiDi>00630414595832</udiDi>
    <basicUdiDi>0405686900765W2</basicUdiDi>
    <tradeName>Atellica CH Ammonia (Amm)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Amm</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>W01010301</emdnCode>
    <emdnDescription>AMMONIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097529</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:10.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595825</udiDi>
    <basicUdiDi>0405686900760VQ</basicUdiDi>
    <tradeName>Atellica CH Albumin BCP (AlbP)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ALBP</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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:07.241Z</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>00630414595726</udiDi>
    <basicUdiDi>0405686900737VV</basicUdiDi>
    <tradeName>Atellica CH A-LYTE IMT Diluent (IMT Diluent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_IMT Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:03.240Z</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>00630414594965</udiDi>
    <basicUdiDi>0405686900838W4</basicUdiDi>
    <tradeName>ADVIA Autoslide Giemsa Stain</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_INST_Autoslide Giemsa Stain</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10718483</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:00.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414592503</udiDi>
    <basicUdiDi>0405686900750VM</basicUdiDi>
    <tradeName>ADVIA Centaur Vitamin D Total</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_KIT_VitD</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>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10699201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:52.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414592497</udiDi>
    <basicUdiDi>0405686900804VK</basicUdiDi>
    <tradeName>ADVIA Centaur Vitamin D Total (VitD) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_VitD_QC</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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10699200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:50.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414586212</udiDi>
    <basicUdiDi>0405686900744VS</basicUdiDi>
    <tradeName>ADVIA Centaur Vitamin D Total Diluent (VitD DIL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_VitD_Dil</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10494100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:49.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414574028</udiDi>
    <basicUdiDi>0405686900806VP</basicUdiDi>
    <tradeName>ADVIA Centaur® CA 19-9™</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_CA 19-9</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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10491244</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:48.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414558400</udiDi>
    <basicUdiDi>0405686900787WC</basicUdiDi>
    <tradeName>ADVIA ® 120/2120/2120i EZ WASH</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_EZ Wash</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10285021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:45.616Z</lastUpdated>
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    <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>
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  <row>
    <udiDi>00630414535418</udiDi>
    <basicUdiDi>0405686900788WE</basicUdiDi>
    <tradeName>ADVIA Centaur® FT4</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_FT4</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>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10282218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:43.243Z</lastUpdated>
  </row>
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    <udiDi>00630414526768</udiDi>
    <basicUdiDi>0405686900741VL</basicUdiDi>
    <tradeName>ADVIA® Chemistry ISE Buffer</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_ISE Buffer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10321715</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:41.621Z</lastUpdated>
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    <udiDi>00630414503929</udiDi>
    <basicUdiDi>0405686900771VV</basicUdiDi>
    <tradeName>ADVIA® Autoslide Wright Giemsa Stain</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Autoslide Wright Giemsa Stain</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10327568</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:39.218Z</lastUpdated>
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    <udiDi>00630414491509</udiDi>
    <basicUdiDi>0405686900769WA</basicUdiDi>
    <tradeName>ADVIA® Autoslide Rinse</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Autoslide Rinse</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10325262</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:38.358Z</lastUpdated>
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    <udiDi>00630414479996</udiDi>
    <basicUdiDi>0405686900747VY</basicUdiDi>
    <tradeName>ADVIA Centaur® HAV IgM</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_KIT_aHAVM</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>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309083</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:38.333Z</lastUpdated>
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</eudamedExport>