<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>03770024131031</udiDi>
    <basicUdiDi>B-03770024131031</basicUdiDi>
    <tradeName>mAbXmise GTDM</tradeName>
    <deviceName>mAbXmise – Quantification kit Belatacept or Abatacept</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTDM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:33.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024131024</udiDi>
    <basicUdiDi>B-03770024131024</basicUdiDi>
    <tradeName>mAbXmise OTDM1</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification Kit Multiplex Nivolumab, Pembrolizumab, Trastuzumab, Cetuximab, Bevacizumab, Ipilimumab, Rituximab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080704</emdnCode>
    <emdnDescription>RITUXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OTDM1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:32.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024131017</udiDi>
    <basicUdiDi>B-03770024131017</basicUdiDi>
    <tradeName>mAbXmise ITDM1</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification Kit Multiplex Infliximab &amp; Adalimumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITDM1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:32.147Z</lastUpdated>
  </row>
</eudamedExport>