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<eudamedExport entity="devices">
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    <udiDi>00630414596013</udiDi>
    <basicUdiDi>0405686901904VX</basicUdiDi>
    <tradeName>Atellica CH Valproic Acid (VPA)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_VPA</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>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097512</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:53.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596006</udiDi>
    <basicUdiDi>0405686901776WE</basicUdiDi>
    <tradeName>Atellica CH Theophylline (Theo)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Theophylline</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>W0102080402</emdnCode>
    <emdnDescription>THEOPHYLLINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097513</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:52.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595993</udiDi>
    <basicUdiDi>0405686901759WE</basicUdiDi>
    <tradeName>Atellica CH Phenobarbital (Phnb)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_phnb</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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097514</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:51.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595962</udiDi>
    <basicUdiDi>0405686901778WJ</basicUdiDi>
    <tradeName>Atellica CH Tobramycin (Tob)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_TOB</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>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097517</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:47.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595863</udiDi>
    <basicUdiDi>0405686901847WC</basicUdiDi>
    <tradeName>Atellica CH Digoxin (Dgn)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_DGN</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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097526</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:40.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414238340</udiDi>
    <basicUdiDi>0405686901868WL</basicUdiDi>
    <tradeName>Atellica CH Tacrolimus (TACR)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_TACR</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>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097542</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:27.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414238081</udiDi>
    <basicUdiDi>0405686901857WF</basicUdiDi>
    <tradeName>Atellica CH Mycophenolic Acid (MPA)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_MPA</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>W0102080605</emdnCode>
    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097540</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:21.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414220673</udiDi>
    <basicUdiDi>0405686901863WA</basicUdiDi>
    <tradeName>Atellica CH Procainamide (PROC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Procainamide</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>W0102080107</emdnCode>
    <emdnDescription>PROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097538</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:04.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414220659</udiDi>
    <basicUdiDi>0405686901860W4</basicUdiDi>
    <tradeName>Atellica CH N-Acetylprocainamide (NAPA)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_N-Acetylprocainamide</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>W0102080106</emdnCode>
    <emdnDescription>N-ACETYLPROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097537</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:03.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768029615</udiDi>
    <basicUdiDi>0405686901308V9</basicUdiDi>
    <tradeName>Emit 2000 Sirolimus Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Sirolimus 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>W0102080604</emdnCode>
    <emdnDescription>RAPAMYCIN (SIROLIMUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:47.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023316</udiDi>
    <basicUdiDi>0405686901118V2</basicUdiDi>
    <tradeName>Emit® 2000 Gentamicin Plus Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus 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>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445335</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:13.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023255</udiDi>
    <basicUdiDi>0405686901254VB</basicUdiDi>
    <tradeName>Emit® 2000 Digoxin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Digoxin 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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445317</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:12.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768022111</udiDi>
    <basicUdiDi>0405686901305V3</basicUdiDi>
    <tradeName>Dimension Sirolimus Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_SIRO</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>W0102080604</emdnCode>
    <emdnDescription>RAPAMYCIN (SIROLIMUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10464331</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:06.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768017421</udiDi>
    <basicUdiDi>0405686901287VS</basicUdiDi>
    <tradeName>Emit 2000 N-Acetylprocainamide Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide 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>W0102080106</emdnCode>
    <emdnDescription>N-ACETYLPROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:00.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768017407</udiDi>
    <basicUdiDi>0405686901159VG</basicUdiDi>
    <tradeName>Emit 2000 Phenobarbital Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Phenobarbital 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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:59.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768017384</udiDi>
    <basicUdiDi>0405686901161V3</basicUdiDi>
    <tradeName>Emit 2000 Phenytoin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Phenytoin 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>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:57.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005619</udiDi>
    <basicUdiDi>0405686901170V4</basicUdiDi>
    <tradeName>Dimension Phenytoin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_PTN</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>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:56.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005596</udiDi>
    <basicUdiDi>0405686901163V7</basicUdiDi>
    <tradeName>Dimension Phenobarbital Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_PHNO</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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444933</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:56.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005381</udiDi>
    <basicUdiDi>0405686901202UQ</basicUdiDi>
    <tradeName>Dimension Tobramycin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_TOBR</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>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444928</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:54.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001666</udiDi>
    <basicUdiDi>0405686901310UU</basicUdiDi>
    <tradeName>Emit 2000 Tacrolimus Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Tacrolimus 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>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445397</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:30.504Z</lastUpdated>
  </row>
</eudamedExport>