<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05700573004546</udiDi>
    <basicUdiDi>570057R0301P3007C008501N9</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030124</emdnCode>
    <emdnDescription>CANCER ANTIGEN P16</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA783</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:07.526Z</lastUpdated>
  </row>
</eudamedExport>