<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-4030PAEDX4T</udiDi>
    <basicUdiDi>B-4030PAEDX4T</basicUdiDi>
    <tradeName>Anti-Epileptic Drugs Expanded Panel Reagent Set</tradeName>
    <deviceName>Anti-Epileptic Drugs Expanded Panel Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4030 P AEDX</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:07:07.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4010PAEDGJ</udiDi>
    <basicUdiDi>B-4010PAEDGJ</basicUdiDi>
    <tradeName>Anti-Epileptic Drugs Basic Panel Reagent Set</tradeName>
    <deviceName>Anti-Epileptid Drugs Basic Panel Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4010 P AED</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:31.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33710GA</udiDi>
    <basicUdiDi>B-33710GA</basicUdiDi>
    <tradeName>Access Digoxin (reagent pack)</tradeName>
    <deviceName>Access Digoxin (reagent pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33710</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:33.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20000E4</udiDi>
    <basicUdiDi>B-20000E4</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Amiodarone in Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080199</emdnCode>
    <emdnDescription>CARDIOVASCULAR TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:16.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-15500FM</udiDi>
    <basicUdiDi>B-15500FM</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Levetiracetam in Serum / Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080215</emdnCode>
    <emdnDescription>LEVETIRACETAM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:29.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14100ES</udiDi>
    <basicUdiDi>B-14100ES</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Antiepileptics in Serum / Plasma by UHPLC</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T04:48:15.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14000EM</udiDi>
    <basicUdiDi>B-14000EM</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit, advanced,for Antiepileptics in Serum / Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T03:08:04.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023248</udiDi>
    <basicUdiDi>0405686901218V7</basicUdiDi>
    <tradeName>Emit 2000 Valproic Acid Assay</tradeName>
    <deviceName></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>10445314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:45:01.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250445</udiDi>
    <basicUdiDi>B-08683548250445</basicUdiDi>
    <tradeName>RapidFor™ Valproic Acid Rapid Test Kit (FIA)</tradeName>
    <deviceName>Valproic Acid Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:01.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250438</udiDi>
    <basicUdiDi>B-08683548250438</basicUdiDi>
    <tradeName>RapidFor™ Vancomycin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Vancomycin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:01.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250384</udiDi>
    <basicUdiDi>B-08683548250384</basicUdiDi>
    <tradeName>RapidFor™ Phenytoin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Phenytoin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO27</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:53.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250360</udiDi>
    <basicUdiDi>B-08683548250360</basicUdiDi>
    <tradeName>RapidFor™ Methotrexate Rapid Test Kit (FIA)</tradeName>
    <deviceName>Methotrexate Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080501</emdnCode>
    <emdnDescription>METHOTREXATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:48.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250353</udiDi>
    <basicUdiDi>B-08683548250353</basicUdiDi>
    <tradeName>RapidFor™ Mycophenolic Acid Rapid Test Kit (FIA)</tradeName>
    <deviceName>Mycophenolic Acid Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080605</emdnCode>
    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:48.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250315</udiDi>
    <basicUdiDi>B-08683548250315</basicUdiDi>
    <tradeName>RapidFor™ Digoxin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Digoxin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:41.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250278</udiDi>
    <basicUdiDi>B-08683548250278</basicUdiDi>
    <tradeName>RapidFor™ Carbamazepine Rapid Test Kit (FIA)</tradeName>
    <deviceName>Carbamazepine Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:36.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457521</udiDi>
    <basicUdiDi>B-08437013457521</basicUdiDi>
    <tradeName>Promonitor-RTX</tradeName>
    <deviceName>Promonitor-RTX</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5130230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:36.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457514</udiDi>
    <basicUdiDi>B-08437013457514</basicUdiDi>
    <tradeName>Promonitor-GLM</tradeName>
    <deviceName>Promonitor-GLM</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5200230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:35.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457507</udiDi>
    <basicUdiDi>B-08437013457507</basicUdiDi>
    <tradeName>Promonitor-ANTI-ETN</tradeName>
    <deviceName>Promonitor-ANTI-ETN</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5120230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:34.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457491</udiDi>
    <basicUdiDi>B-08437013457491</basicUdiDi>
    <tradeName>Promonitor-ETN</tradeName>
    <deviceName>Promonitor-ETN</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5110230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:31.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457354</udiDi>
    <basicUdiDi>B-08437013457354</basicUdiDi>
    <tradeName>Promonitor-ANTI-GLM</tradeName>
    <deviceName>Promonitor-ANTI-GLM</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5210230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:30.287Z</lastUpdated>
  </row>
</eudamedExport>