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<eudamedExport entity="devices">
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    <udiDi>03532672000158</udiDi>
    <basicUdiDi>B-03532672000158</basicUdiDi>
    <tradeName>i-Tracker Anti-Rituximab</tradeName>
    <deviceName>i-Tracker Anti-Rituximab</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>CTR 003-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:09.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000141</udiDi>
    <basicUdiDi>B-03532672000141</basicUdiDi>
    <tradeName>i-Tracker Rituximab</tradeName>
    <deviceName>i-Tracker Rituximab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080704</emdnCode>
    <emdnDescription>RITUXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTR 002-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:08.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000134</udiDi>
    <basicUdiDi>B-03532672000134</basicUdiDi>
    <tradeName>i-Tracker Anti-Golimumab</tradeName>
    <deviceName>i-Tracker Anti-Golimumab</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>CTG 003-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:07.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000127</udiDi>
    <basicUdiDi>B-03532672000127</basicUdiDi>
    <tradeName>i-Tracker Golimumab</tradeName>
    <deviceName>i-Tracker Golimumab</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>CTG 002-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:03.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000097</udiDi>
    <basicUdiDi>B-03532672000097</basicUdiDi>
    <tradeName>i-Tracker Anti-Certolizumab</tradeName>
    <deviceName>i-Tracker Anti-Certolizumab</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>CTC 003-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:02.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000080</udiDi>
    <basicUdiDi>B-03532672000080</basicUdiDi>
    <tradeName>i-Tracker Certolizumab</tradeName>
    <deviceName>i-Tracker Certolizumab</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>CTC 002-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:01.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000073</udiDi>
    <basicUdiDi>B-03532672000073</basicUdiDi>
    <tradeName>i-Tracker Anti-Vedolizumab</tradeName>
    <deviceName>i-Tracker Anti-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 003-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:01.131Z</lastUpdated>
  </row>
  <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>03532672000028</udiDi>
    <basicUdiDi>B-03532672000028</basicUdiDi>
    <tradeName>i-Tracker Infliximab</tradeName>
    <deviceName>i-Tracker Infliximab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTI 002-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:54.726Z</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>03532672000004</udiDi>
    <basicUdiDi>B-03532672000004</basicUdiDi>
    <tradeName>i-Tracker Adalimumab</tradeName>
    <deviceName>i-Tracker Adalimumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTA 002-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:49.938Z</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>08437013457538</udiDi>
    <basicUdiDi>8437013457Promonitor008H5</basicUdiDi>
    <tradeName>Promonitor-ANTI-RTX</tradeName>
    <deviceName>Promonitor-ANTI-RTX</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>W0102080704</emdnCode>
    <emdnDescription>RITUXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5140230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:52.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457484</udiDi>
    <basicUdiDi>8437013457Promonitor004GV</basicUdiDi>
    <tradeName>Promonitor-ANTI-ADL</tradeName>
    <deviceName>Promonitor-ANTI-ADL</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>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5090230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:48.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437013457477</udiDi>
    <basicUdiDi>8437013457Promonitor003GT</basicUdiDi>
    <tradeName>Promonitor-ADL</tradeName>
    <deviceName>Promonitor-ADL</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>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:47.734Z</lastUpdated>
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    <udiDi>08437013457453</udiDi>
    <basicUdiDi>8437013457Promonitor016H4</basicUdiDi>
    <tradeName>Promonitor CONTROL-ADL</tradeName>
    <deviceName>Promonitor CONTROL-ADL</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>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54415C0000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:46.938Z</lastUpdated>
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    <udiDi>08437013457446</udiDi>
    <basicUdiDi>8437013457Promonitor015H2</basicUdiDi>
    <tradeName>Promonitor CONTROL-IFX</tradeName>
    <deviceName>Promonitor CONTROL-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>54315C0000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:46.140Z</lastUpdated>
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  <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>
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