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<eudamedExport entity="devices">
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    <udiDi>00630414598819</udiDi>
    <basicUdiDi>0405686901848WE</basicUdiDi>
    <tradeName>Atellica IM Digoxin (Dig)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Digoxin</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>10995557</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:48:59.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414177410</udiDi>
    <basicUdiDi>0405686901808W2</basicUdiDi>
    <tradeName>ADVIA Centaur Digoxin</tradeName>
    <deviceName></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>10309981</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:45:14.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024131031</udiDi>
    <basicUdiDi>B-03770024131031</basicUdiDi>
    <tradeName>mAbXmise GTDM</tradeName>
    <deviceName>mAbXmise – Quantification kit Belatacept or Abatacept</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTDM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:33.748Z</lastUpdated>
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  <row>
    <udiDi>03770024131024</udiDi>
    <basicUdiDi>B-03770024131024</basicUdiDi>
    <tradeName>mAbXmise OTDM1</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification Kit Multiplex Nivolumab, Pembrolizumab, Trastuzumab, Cetuximab, Bevacizumab, Ipilimumab, Rituximab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080704</emdnCode>
    <emdnDescription>RITUXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OTDM1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:32.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024131017</udiDi>
    <basicUdiDi>B-03770024131017</basicUdiDi>
    <tradeName>mAbXmise ITDM1</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification Kit Multiplex Infliximab &amp; Adalimumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITDM1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:32.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768025136</udiDi>
    <basicUdiDi>0405686901242V4</basicUdiDi>
    <tradeName>Dimension Cyclosporine A Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_CSA</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>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10285193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:27.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005510</udiDi>
    <basicUdiDi>0405686901252V7</basicUdiDi>
    <tradeName>Dimension Digitoxin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_DGTX</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>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444932</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:19.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001543</udiDi>
    <basicUdiDi>0405686901046V2</basicUdiDi>
    <tradeName>Emit Amikacin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_KIT_Amikacin 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>W0102080301</emdnCode>
    <emdnDescription>AMIKACIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445383</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:07.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001451</udiDi>
    <basicUdiDi>0405686901249VJ</basicUdiDi>
    <tradeName>Emit 2000 Cyclosporine Specific Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Cyclosporine Specific 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>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445375</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:05.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001413</udiDi>
    <basicUdiDi>0405686901050UR</basicUdiDi>
    <tradeName>Emit Caffeine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_KIT_Caffeine 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>W0102080401</emdnCode>
    <emdnDescription>CAFFEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445371</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:00.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001086</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>10445333</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:43.520Z</lastUpdated>
  </row>
  <row>
    <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>00630414961262</udiDi>
    <basicUdiDi>0405686901447VQ</basicUdiDi>
    <tradeName>IMMULITE 2000 Digitoxin</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Dgtn</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>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381538</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:05.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961286</udiDi>
    <basicUdiDi>0405686901448VS</basicUdiDi>
    <tradeName>IMMULITE 2000 Digoxin</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_KIT_Dgxn</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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381529</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:02.699Z</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>00630414598826</udiDi>
    <basicUdiDi>0405686901848WE</basicUdiDi>
    <tradeName>Atellica IM Digoxin (Dig)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Digoxin</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>10995558</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:09.812Z</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>00630414177427</udiDi>
    <basicUdiDi>0405686901808W2</basicUdiDi>
    <tradeName>ADVIA Centaur Digoxin</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_DIG</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>10322129</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:16.110Z</lastUpdated>
  </row>
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