<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00842768001628</udiDi>
    <basicUdiDi>0405686901303UX</basicUdiDi>
    <tradeName>Emit tox Salicylic Acid Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Salicylic Acid Calibrators</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>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445393</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:25.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001611</udiDi>
    <basicUdiDi>0405686901302UV</basicUdiDi>
    <tradeName>Emit tox Salicylic Acid Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Salicylic 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>W0102090213</emdnCode>
    <emdnDescription>SALICYLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445392</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:12.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001604</udiDi>
    <basicUdiDi>0405686901048V6</basicUdiDi>
    <tradeName>Emit tox Serum Barbiturate Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_KIT_Barbiturate 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>W0102090103</emdnCode>
    <emdnDescription>BARBITURATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445391</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:10.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001581</udiDi>
    <basicUdiDi>0405686901049V8</basicUdiDi>
    <tradeName>Emit tox Serum Benzodiazepine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_KIT_Benzodiazepine 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>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445388</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:09.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001574</udiDi>
    <basicUdiDi>0405686901186VK</basicUdiDi>
    <tradeName>Emit tox Serum Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Serum Calibrators</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>10445387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:08.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001390</udiDi>
    <basicUdiDi>0405686901226V6</basicUdiDi>
    <tradeName>Emit Lidocaine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_KIT_Lidocaine 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>W0102080105</emdnCode>
    <emdnDescription>LIDOCAINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445369</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:05.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001383</udiDi>
    <basicUdiDi>0405686901051UT</basicUdiDi>
    <tradeName>Emit Methotrexate Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_KIT_Methotrexate 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>W0102080501</emdnCode>
    <emdnDescription>METHOTREXATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445368</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:04.029Z</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>00842768001116</udiDi>
    <basicUdiDi>0405686901222UW</basicUdiDi>
    <tradeName>Emit 2000 Vancomycin Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Vancomycin Calibrators</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>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445337</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:01.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001109</udiDi>
    <basicUdiDi>0405686901221UU</basicUdiDi>
    <tradeName>Emit 2000 Vancomycin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Vancomycin 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>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445336</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:59.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001079</udiDi>
    <basicUdiDi>0405686901204UU</basicUdiDi>
    <tradeName>Emit 2000 Tobramycin Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Tobramycin Calibrators</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>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445331</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:57.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001062</udiDi>
    <basicUdiDi>0405686901203US</basicUdiDi>
    <tradeName>Emit 2000 Tobramycin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Tobramycin 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>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445330</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:56.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001055</udiDi>
    <basicUdiDi>0405686901299VZ</basicUdiDi>
    <tradeName>Emit 2000 Quinidine Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Quinidine Calibrators</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>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:55.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001048</udiDi>
    <basicUdiDi>0405686901298VX</basicUdiDi>
    <tradeName>Emit 2000 Quinidine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Quinidine 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>W0102080109</emdnCode>
    <emdnDescription>QUINIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445327</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:52.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001031</udiDi>
    <basicUdiDi>0405686901197VQ</basicUdiDi>
    <tradeName>Emit 2000 Theophylline Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Theophylline Calibrators</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>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445325</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:51.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001024</udiDi>
    <basicUdiDi>0405686901196VN</basicUdiDi>
    <tradeName>Emit 2000 Theophylline Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Theophylline 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>W0102080402</emdnCode>
    <emdnDescription>THEOPHYLLINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445324</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:50.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001017</udiDi>
    <basicUdiDi>0405686901288VU</basicUdiDi>
    <tradeName>Emit 2000 N-Acetylprocainamide Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide Calibrators</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>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445322</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:48.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000997</udiDi>
    <basicUdiDi>0405686901294VP</basicUdiDi>
    <tradeName>Emit 2000 Procainamide Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Procainamide Calibrators</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>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445319</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:46.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000980</udiDi>
    <basicUdiDi>0405686901293VM</basicUdiDi>
    <tradeName>Emit 2000 Procainamide Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Procainamide 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>W0102080107</emdnCode>
    <emdnDescription>PROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445318</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:44.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000959</udiDi>
    <basicUdiDi>0405686901219V9</basicUdiDi>
    <tradeName>Emit 2000 Valproic Acid Calibrators</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Valproic Acid Calibrators</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>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445313</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:44.018Z</lastUpdated>
  </row>
</eudamedExport>