<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598196506</udiDi>
    <basicUdiDi>B-04050598196506</basicUdiDi>
    <tradeName>IDKmonitor® Infliximab free ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Infliximab free ADA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9650</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598196520</udiDi>
    <basicUdiDi>B-04050598196520</basicUdiDi>
    <tradeName>IDKmonitor® Adalimumab free ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab free ADA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9652</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000412254</udiDi>
    <basicUdiDi>5430000412710701QC</basicUdiDi>
    <tradeName>Secukinumab ELISA</tradeName>
    <deviceName>Secukinumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710701</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:39.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000412100</udiDi>
    <basicUdiDi>5430000412710601Q7</basicUdiDi>
    <tradeName>Ustekinumab ELISA</tradeName>
    <deviceName>Ustekinumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710601</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:34.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000412094</udiDi>
    <basicUdiDi>5430000412710401PV</basicUdiDi>
    <tradeName>Golimumab ELISA</tradeName>
    <deviceName>Golimumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710401</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:33.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000412070</udiDi>
    <basicUdiDi>5430000412710501Q2</basicUdiDi>
    <tradeName>Vedolizumab ELISA</tradeName>
    <deviceName>Vedolizumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710501</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:33.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000412063</udiDi>
    <basicUdiDi>5430000412710301PQ</basicUdiDi>
    <tradeName>Anti-Adalimumab ELISA</tradeName>
    <deviceName>Anti-Adalimumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710301</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:28.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000412056</udiDi>
    <basicUdiDi>5430000412710201PK</basicUdiDi>
    <tradeName>Adalimumab ELISA</tradeName>
    <deviceName>Adalimumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710201</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:28.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000412032</udiDi>
    <basicUdiDi>5430000412710001P9</basicUdiDi>
    <tradeName>Infliximab ELISA</tradeName>
    <deviceName>Infliximab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:27.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273218985</udiDi>
    <basicUdiDi>50552732CCELISA0649X</basicUdiDi>
    <tradeName>ConcizuTrace™ ELISA</tradeName>
    <deviceName>ConcizuTrace™ ELISA</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CZM10591</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:35.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024131079</udiDi>
    <basicUdiDi>3770024131INF-ADAX3</basicUdiDi>
    <tradeName>mAbXmise IADA1</tradeName>
    <deviceName>mAbXmise – Anti-drug antibodies quantification  Kit multiplex ANTI-Infliximab &amp; ANTI-Adalimumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IADA1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:57:44.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024131055</udiDi>
    <basicUdiDi>3770024131PNH-TDM7A</basicUdiDi>
    <tradeName>mAbXmise PNHTDM</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification  Kit Eculizumab or Ravulizumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNHTDM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:57:43.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024131048</udiDi>
    <basicUdiDi>3770024131HEM-TDMYZ</basicUdiDi>
    <tradeName>mAbXmise HTDM</tradeName>
    <deviceName>mAbXmise – Monoclonal antibody quantification  Kit Emicizumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HTDM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:57:42.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024131000</udiDi>
    <basicUdiDi>3770024131INF-TDM2V</basicUdiDi>
    <tradeName>mAbXmise ITDM2</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification  Kit Multiplex Infliximab, Adalimumab, Obinutuzumab, Secukinumab, Tocilizumab, Ustekinumab, Vedolizumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITDM2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:57:41.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590220242</udiDi>
    <basicUdiDi>150995905IM36796Z</basicUdiDi>
    <tradeName>Cyclosporine direct RIA KIT</tradeName>
    <deviceName>Cyclosporine direct RIA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3679</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:45:47.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590040031</udiDi>
    <basicUdiDi>150995902OSR6404MV</basicUdiDi>
    <tradeName>Digoxin</tradeName>
    <deviceName>Digoxin</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6404</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:30:22.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590040024</udiDi>
    <basicUdiDi>150995902OSR6403MT</basicUdiDi>
    <tradeName>Digitoxin</tradeName>
    <deviceName>Digitoxin</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6403</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:30:20.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414524450</udiDi>
    <basicUdiDi>0405686901807VY</basicUdiDi>
    <tradeName>ADVIA Centaur Cyclosporine</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_CsA</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>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10335448</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:01.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293591046</udiDi>
    <basicUdiDi>697518250F11410ZU</basicUdiDi>
    <tradeName>Tacrolimus CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Tacrolimus CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11410-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:04:49.641Z</lastUpdated>
  </row>
  <row>
    <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>
</eudamedExport>