<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-PHT706-AE7W</udiDi>
    <basicUdiDi>B-PHT706-AE7W</basicUdiDi>
    <tradeName>PHT Phenytoin(CLIA)</tradeName>
    <deviceName>PHT Phenytoin(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>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHT706-AE10Y, PHT706-AE10N, PHT706-AE20Y, PHT706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:45:13.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PB706-AE3D</udiDi>
    <basicUdiDi>B-PB706-AE3D</basicUdiDi>
    <tradeName>PB Phenobarbital(CLIA)</tradeName>
    <deviceName>PB Phenobarbital(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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB706-AE10Y, PB706-AE10N, PB706-AE20Y, PB706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:32:17.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS9400CF</udiDi>
    <basicUdiDi>B-MS9400CF</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Antidepressants 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>MS9400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:34.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS9300CA</udiDi>
    <basicUdiDi>B-MS9300CA</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Neuroleptics 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>MS9300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:34.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS9200C5</udiDi>
    <basicUdiDi>B-MS9200C5</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Antiepileptic Drugs 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>MS9200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:32.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS9100BY</udiDi>
    <basicUdiDi>B-MS9100BY</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Tricyclic Antidepressants 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>MS9100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:29.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DGAB-R102TF</udiDi>
    <basicUdiDi>B-DGAB-R102TF</basicUdiDi>
    <tradeName>GAB Rapid Test Cassette</tradeName>
    <deviceName>GAB Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080211</emdnCode>
    <emdnDescription>GABAPENTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGAB-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:08:21.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CBZ706-AEW4</udiDi>
    <basicUdiDi>B-CBZ706-AEW4</basicUdiDi>
    <tradeName>CBZ Carbamazepine(CLIA)</tradeName>
    <deviceName>CBZ Carbamazepine(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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBZ706-AE10Y, CBZ706-AE10N, CBZ706-AE20Y, CBZ706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:42.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-811026P3</udiDi>
    <basicUdiDi>B-811026P3</basicUdiDi>
    <tradeName>D-811026P3</tradeName>
    <deviceName>S100β Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:13.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469785SH</udiDi>
    <basicUdiDi>B-469785SH</basicUdiDi>
    <tradeName>Phenobarbital Reagent (PHE 2 x 100)</tradeName>
    <deviceName>Phenobarbital Reagent (PHE 2 x 100)</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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469785</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:27.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469188RR</udiDi>
    <basicUdiDi>B-469188RR</basicUdiDi>
    <tradeName>Phenytoin Reagent (PHY 2 x 100)</tradeName>
    <deviceName>Phenytoin Reagent (PHY 2 x 100)</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>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469188</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:21.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469112QQ</udiDi>
    <basicUdiDi>B-469112QQ</basicUdiDi>
    <tradeName>Carbamazepine Reagent</tradeName>
    <deviceName>Carbamazepine Reagent</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:13.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467995SG</udiDi>
    <basicUdiDi>B-467995SG</basicUdiDi>
    <tradeName>Valproic Acid Reagent (VPA 2 x 100)</tradeName>
    <deviceName>Valproic Acid Reagent (VPA 2 x 100)</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>W0102080206</emdnCode>
    <emdnDescription>FREE VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467995</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:37.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4220PVPAN5</udiDi>
    <basicUdiDi>B-4220PVPAN5</basicUdiDi>
    <tradeName>Valproic Acid Reagent Set</tradeName>
    <deviceName>Valproic Acid 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>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4220 P VPA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:16:50.879Z</lastUpdated>
  </row>
  <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-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>
</eudamedExport>