<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FRMF000041783ONCOGRAMPA</udiDi>
    <basicUdiDi>B-FRMF000041783ONCOGRAMPA</basicUdiDi>
    <tradeName>Oncogramme</tradeName>
    <deviceName>Oncogramme for Colon</deviceName>
    <manufacturerName>Oncomedics SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000041783</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>ONCOGRAM2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:46:45.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DIG706-AEQV</udiDi>
    <basicUdiDi>B-DIG706-AEQV</basicUdiDi>
    <tradeName>DIG Digoxin(CLIA)</tradeName>
    <deviceName>DIG Digoxin(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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIG706-AE10Y, DIG706-AE10N, DIG706-AE20Y, DIG706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:08:32.321Z</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-CsA706-AEB2</udiDi>
    <basicUdiDi>B-CsA706-AEB2</basicUdiDi>
    <tradeName>CsA Cyclosporine(CLIA)</tradeName>
    <deviceName>CsA Cyclosporine(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>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CsA706-AE10Y, CsA706-AE10N, CsA706-AE20Y, CsA706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:34.704Z</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-474824RA</udiDi>
    <basicUdiDi>B-474824RA</basicUdiDi>
    <tradeName>Vancomycin Reagent (VANC 2 x 100)</tradeName>
    <deviceName>Vancomycin Reagent (VANC 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>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>474824</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:27.451Z</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-469137R8</udiDi>
    <basicUdiDi>B-469137R8</basicUdiDi>
    <tradeName>Gentamicin Reagent (GEN 2 x 100)</tradeName>
    <deviceName>Gentamicin Reagent (GEN 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>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469137</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:18.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469126R3</udiDi>
    <basicUdiDi>B-469126R3</basicUdiDi>
    <tradeName>Theophylline Reagent (THE 2 x 100)</tradeName>
    <deviceName>Theophylline Reagent (THE 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>W0102080402</emdnCode>
    <emdnDescription>THEOPHYLLINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469126</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:14.700Z</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-467983S9</udiDi>
    <basicUdiDi>B-467983S9</basicUdiDi>
    <tradeName>Tobramycin Reagent (TOB 2 x 100)</tradeName>
    <deviceName>Tobramycin Reagent (TOB 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>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467983</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:36.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4320PMPAM9</udiDi>
    <basicUdiDi>B-4320PMPAM9</basicUdiDi>
    <tradeName>Mycophenolic Acid Reagent Set</tradeName>
    <deviceName>Mycophenolic 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>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4320 P MPA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:51.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4300PABXJP</udiDi>
    <basicUdiDi>B-4300PABXJP</basicUdiDi>
    <tradeName>Antibiotics Reagent Set</tradeName>
    <deviceName>Antibiotics 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>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4300 P ABX</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:33.815Z</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-4200PTACKQ</udiDi>
    <basicUdiDi>B-4200PTACKQ</basicUdiDi>
    <tradeName>Tacrolimus Reagent Set</tradeName>
    <deviceName>Tacrolimus 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>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4200 P TAC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:16:46.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4180PIMMNG</udiDi>
    <basicUdiDi>B-4180PIMMNG</basicUdiDi>
    <tradeName>Immunosuppressants Reagent Set</tradeName>
    <deviceName>Immunosuppressants 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>W0102080604</emdnCode>
    <emdnDescription>RAPAMYCIN (SIROLIMUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4180 P IMM</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:28.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4160PCARKW</udiDi>
    <basicUdiDi>B-4160PCARKW</basicUdiDi>
    <tradeName>Cardiac Medication Reagent Set</tradeName>
    <deviceName>Cardiac Medication 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>W0102080199</emdnCode>
    <emdnDescription>CARDIOVASCULAR TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4160 P CAR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:21.746Z</lastUpdated>
  </row>
</eudamedExport>