<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08437013457392</udiDi>
    <basicUdiDi>8437013457Promonitor014GY</basicUdiDi>
    <tradeName>Promonitor-ANTI-UTK</tradeName>
    <deviceName>Promonitor-ANTI-UTK</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</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>5381530000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:41.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457385</udiDi>
    <basicUdiDi>8437013457Promonitor013GW</basicUdiDi>
    <tradeName>Promonitor-UTK</tradeName>
    <deviceName>Promonitor-UTK</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</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>5371530000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:40.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457088</udiDi>
    <basicUdiDi>8437013457Promonitor002GR</basicUdiDi>
    <tradeName>Promonitor-ANTI-IFX</tradeName>
    <deviceName>Promonitor-ANTI-IFX</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</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>5070230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:39.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457071</udiDi>
    <basicUdiDi>8437013457Promonitor001GP</basicUdiDi>
    <tradeName>Promonitor-IFX</tradeName>
    <deviceName>Promonitor-IFX</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</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>5060230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:24.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891328337</udiDi>
    <basicUdiDi>803389132CHORUSGLM0085</basicUdiDi>
    <tradeName>CHORUS Promonitor GOLIMUMAB</tradeName>
    <deviceName>CHORUS Promonitor GOLIMUMAB</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</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>86708</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:44.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891328313</udiDi>
    <basicUdiDi>803389132CHORUSETN009C</basicUdiDi>
    <tradeName>CHORUS Promonitor ETANERCEPT</tradeName>
    <deviceName>CHORUS Promonitor ETANERCEPT</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080703</emdnCode>
    <emdnDescription>ETANERCEP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86706</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:42.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891324506</udiDi>
    <basicUdiDi>803389132CHORUSUTK00ED</basicUdiDi>
    <tradeName>CHORUS Promonitor USTEKINUMAB</tradeName>
    <deviceName>CHORUS Promonitor USTEKINUMAB</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</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>86712</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:35.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891328344</udiDi>
    <basicUdiDi>803389132CHORUSAGLM006J</basicUdiDi>
    <tradeName>CHORUS Promonitor ANTI-GOLIMUMAB</tradeName>
    <deviceName>CHORUS Promonitor ANTI-GOLIMUMAB</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</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>86709</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:15:41.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000412049</udiDi>
    <basicUdiDi>5430000412710101PE</basicUdiDi>
    <tradeName>Anti-Infliximab ELISA</tradeName>
    <deviceName>Anti-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>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710101</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:09:43.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095070204</udiDi>
    <basicUdiDi>4049095GN30430000BC</basicUdiDi>
    <tradeName>04049095070204</tradeName>
    <deviceName>RIDA®QUICK ADM Monitoring</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN3043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:50:21.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095070167</udiDi>
    <basicUdiDi>4049095GN30410000AN</basicUdiDi>
    <tradeName>04049095070167</tradeName>
    <deviceName>RIDA®QUICK IFX Monitoring</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN3041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:50:16.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672001964</udiDi>
    <basicUdiDi>353267CTU002BXB</basicUdiDi>
    <tradeName>i-Tracker Ustekinumab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTU 002-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:10.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000257</udiDi>
    <basicUdiDi>353267CTA003TAPH</basicUdiDi>
    <tradeName>i-Tracker Anti-Adalimumab Total Ab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTA 003T-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:55.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000219</udiDi>
    <basicUdiDi>353267CTO003AVA</basicUdiDi>
    <tradeName>i-Tracker Anti-Ocrelizumab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTO 003-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:53.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000202</udiDi>
    <basicUdiDi>353267CTO002AV7</basicUdiDi>
    <tradeName>i-Tracker Ocrelizumab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTO 002-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:53.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000240</udiDi>
    <basicUdiDi>353267CTI003TASR</basicUdiDi>
    <tradeName>i-Tracker Anti-Infliximab Total Ab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTI 003T-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:51.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000172</udiDi>
    <basicUdiDi>353267CTRZ003A95</basicUdiDi>
    <tradeName>i-Tracker Anti-Risankizumab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTRZ 003-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:37.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000165</udiDi>
    <basicUdiDi>353267CTRZ002A92</basicUdiDi>
    <tradeName>i-Tracker Risankizumab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTRZ 002-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:33.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000110</udiDi>
    <basicUdiDi>353267CTE003ARU</basicUdiDi>
    <tradeName>i-Tracker Anti-Etanercept</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTE 003-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:32.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000103</udiDi>
    <basicUdiDi>353267CTE002ARR</basicUdiDi>
    <tradeName>i-Tracker Etanercept</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080703</emdnCode>
    <emdnDescription>ETANERCEP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTE 002-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:32.150Z</lastUpdated>
  </row>
</eudamedExport>