<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00894354002113</udiDi>
    <basicUdiDi>B-00894354002113</basicUdiDi>
    <tradeName>My5-FU Sample Stabilizer Kit</tradeName>
    <deviceName>My5-FU Sample Stabilizer Kit</deviceName>
    <manufacturerName>Saladax Biomedical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007957</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080599</emdnCode>
    <emdnDescription>ANTI-NEOPLASTIC TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5FU-STB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:44.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894354002441</udiDi>
    <basicUdiDi>B-00894354002441</basicUdiDi>
    <tradeName>MyCare Insite Total Aripiprazole Test</tradeName>
    <deviceName>MyCare Insite Total Aripiprazole Test</deviceName>
    <manufacturerName>Saladax Biomedical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007957</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160499</emdnCode>
    <emdnDescription>TDM RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-MCI-32</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:42.202Z</lastUpdated>
  </row>
</eudamedExport>