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<eudamedExport entity="devices">
  <row>
    <udiDi>03532672000899</udiDi>
    <basicUdiDi>B-03532672000899</basicUdiDi>
    <tradeName>IMMUNO-TROL Anti-Adalimumab</tradeName>
    <deviceName>IMMUNO-TROL Anti-Adalimumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTA 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:57.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000882</udiDi>
    <basicUdiDi>B-03532672000882</basicUdiDi>
    <tradeName>IMMUNO-TROL Adalimumab</tradeName>
    <deviceName>IMMUNO-TROL Adalimumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTA 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:40:56.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000417</udiDi>
    <basicUdiDi>B-03532672000417</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Rituximab</tradeName>
    <deviceName>IMMUNO-TROL 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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTR 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:44.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000394</udiDi>
    <basicUdiDi>B-03532672000394</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Golimumab</tradeName>
    <deviceName>IMMUNO-TROL 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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTG 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:42.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000387</udiDi>
    <basicUdiDi>B-03532672000387</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Golimumab</tradeName>
    <deviceName>IMMUNO-TROL i-Tracker Golimumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTG 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:42.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000400</udiDi>
    <basicUdiDi>B-03532672000400</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Rituximab</tradeName>
    <deviceName>IMMUNO-TROL i-Tracker Rituximab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTR 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:40.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000356</udiDi>
    <basicUdiDi>B-03532672000356</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Certolizumab</tradeName>
    <deviceName>IMMUNO-TROL 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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTC 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:26.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000332</udiDi>
    <basicUdiDi>B-03532672000332</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Vedolizumab</tradeName>
    <deviceName>IMMUNO-TROL 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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTV 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:21.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000325</udiDi>
    <basicUdiDi>B-03532672000325</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Vedolizumab</tradeName>
    <deviceName>IMMUNO-TROL i-Tracker Vedolizumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTV 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:21.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000318</udiDi>
    <basicUdiDi>B-03532672000318</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Ustekinumab</tradeName>
    <deviceName>IMMUNO-TROL 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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTU 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:20.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000301</udiDi>
    <basicUdiDi>B-03532672000301</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Ustekinumab</tradeName>
    <deviceName>IMMUNO-TROL i-Tracker Ustekinumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTU 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:16.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000295</udiDi>
    <basicUdiDi>B-03532672000295</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Infliximab</tradeName>
    <deviceName>IMMUNO-TROL 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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTI 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:15.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000288</udiDi>
    <basicUdiDi>B-03532672000288</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Infliximab</tradeName>
    <deviceName>IMMUNO-TROL i-Tracker Infliximab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTI 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:14.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000271</udiDi>
    <basicUdiDi>B-03532672000271</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Adalimumab</tradeName>
    <deviceName>IMMUNO-TROL 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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTA 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:13.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532672000264</udiDi>
    <basicUdiDi>B-03532672000264</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker  Adalimumab</tradeName>
    <deviceName>IMMUNO-TROL i-Tracker Adalimumab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTA 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:39:09.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008915</udiDi>
    <basicUdiDi>B-00884883008915</basicUdiDi>
    <tradeName>00884883008915</tradeName>
    <deviceName>Alinity c TDM Multiconstituent Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P7404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:14.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008434</udiDi>
    <basicUdiDi>B-00884883008434</basicUdiDi>
    <tradeName>00884883008434</tradeName>
    <deviceName>ARCHITECT TDM Multiconstituent Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P04-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:19.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883004856</udiDi>
    <basicUdiDi>B-00884883004856</basicUdiDi>
    <tradeName>00884883004856</tradeName>
    <deviceName>CEDIA Speciality Control Set</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1815440</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:21:03.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005050</udiDi>
    <basicUdiDi>B-00859110005050</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301vt</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:15.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005043</udiDi>
    <basicUdiDi>B-00859110005043</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301ri</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:14.293Z</lastUpdated>
  </row>
</eudamedExport>