<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03532672000066</udiDi>
    <basicUdiDi>B-03532672000066</basicUdiDi>
    <tradeName>i-Tracker Vedolizumab</tradeName>
    <deviceName>i-Tracker Vedolizumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTV 002-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:57.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000059</udiDi>
    <basicUdiDi>B-03532672000059</basicUdiDi>
    <tradeName>i-Tracker Anti-Ustekinumab</tradeName>
    <deviceName>i-Tracker Anti-Ustekinumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTU 003-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:56.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000035</udiDi>
    <basicUdiDi>B-03532672000035</basicUdiDi>
    <tradeName>i-Tracker Anti-Infliximab</tradeName>
    <deviceName>i-Tracker Anti-Infliximab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTI 003-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:55.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000011</udiDi>
    <basicUdiDi>B-03532672000011</basicUdiDi>
    <tradeName>i-Tracker Anti-Adalimumab</tradeName>
    <deviceName>i-Tracker Anti-Adalimumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</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>CTA 003-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:50.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457569</udiDi>
    <basicUdiDi>8437013457Promonitor009H7</basicUdiDi>
    <tradeName>Promonitor-VDZ</tradeName>
    <deviceName>Promonitor-VDZ</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>5391530000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:53.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457408</udiDi>
    <basicUdiDi>8437013457Promonitor010GQ</basicUdiDi>
    <tradeName>Promonitor-ANTI-VDZ</tradeName>
    <deviceName>Promonitor-ANTI-VDZ</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>5401530000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:42.140Z</lastUpdated>
  </row>
  <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>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>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>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>
</eudamedExport>