<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>00192721001487</udiDi>
    <basicUdiDi>0192721U0200100NL</basicUdiDi>
    <tradeName>PGDx elio tissue complete</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal Genome Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026862</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T19:01:57.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00192721001470</udiDi>
    <basicUdiDi>0192721U0200100NL</basicUdiDi>
    <tradeName>PGDx elio tissue complete</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal Genome Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026862</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T19:01:56.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>00192721001241</udiDi>
    <basicUdiDi>0192721U0200400P3</basicUdiDi>
    <tradeName>PGDx elio diversiPhi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal Genome Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026862</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T19:01:54.817Z</lastUpdated>
  </row>
</eudamedExport>