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<eudamedExport entity="devices">
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    <udiDi>00842768000966</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445315</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:37.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000928</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>10445309</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:36.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000140</udiDi>
    <basicUdiDi>0405686901105UR</basicUdiDi>
    <tradeName>Emit Ethosuximide Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Ethosuximide 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>W0102080202</emdnCode>
    <emdnDescription>ETHOSUXIMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445367</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:35.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961095</udiDi>
    <basicUdiDi>0405686901373VL</basicUdiDi>
    <tradeName>IMMULITE 2000 Carbamazepine</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Carbamazepine</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:42.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595979</udiDi>
    <basicUdiDi>0405686901715VS</basicUdiDi>
    <tradeName>Atellica CH Gentamicin (Gent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Gentamicin</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>11097516</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:44.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596037</udiDi>
    <basicUdiDi>0405686901761VZ</basicUdiDi>
    <tradeName>Atellica CH Phenytoin (Phny)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_phny</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>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:58.910Z</lastUpdated>
  </row>
  <row>
    <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>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>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>00842768001376</udiDi>
    <basicUdiDi>0405686901165VB</basicUdiDi>
    <tradeName>Emit Primidone Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Primidone 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>W0102080209</emdnCode>
    <emdnDescription>PRIMIDONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445366</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:03.227Z</lastUpdated>
  </row>
  <row>
    <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>00630414961903</udiDi>
    <basicUdiDi>0405686901400UW</basicUdiDi>
    <tradeName>IMMULITE 2000 Phenytoin</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Phenytoin</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>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381548</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:06.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961828</udiDi>
    <basicUdiDi>0405686901399W6</basicUdiDi>
    <tradeName>IMMULITE 2000 Phenobarbital</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_phenobarb</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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381542</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:57.486Z</lastUpdated>
  </row>
  <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>
  </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>00630414962290</udiDi>
    <basicUdiDi>0405686900228V3</basicUdiDi>
    <tradeName>IMMULITE 2000 Valproic Acid</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Valproic Acid</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>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381544</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:35.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VPA706-AE6V</udiDi>
    <basicUdiDi>B-VPA706-AE6V</basicUdiDi>
    <tradeName>VPA Valproate(CLIA)</tradeName>
    <deviceName>VPA Valproate(CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VPA706-AE10Y, VPA706-AE10N, VPA706-AE20Y, VPA706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:49.061Z</lastUpdated>
  </row>
</eudamedExport>