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<eudamedExport entity="devices">
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    <udiDi>05745000468010</udiDi>
    <basicUdiDi>B-05745000468010</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030010</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468027</udiDi>
    <basicUdiDi>B-05745000468027</basicUdiDi>
    <tradeName>05745000468027</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030021</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468034</udiDi>
    <basicUdiDi>B-05745000468034</basicUdiDi>
    <tradeName>05745000468034</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030013, MFG030019</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468058</udiDi>
    <basicUdiDi>B-05745000468058</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030015</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468065</udiDi>
    <basicUdiDi>B-05745000468065</basicUdiDi>
    <tradeName>05745000468065</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG020002</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468072</udiDi>
    <basicUdiDi>B-05745000468072</basicUdiDi>
    <tradeName>05745000468072</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG020003</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468096</udiDi>
    <basicUdiDi>B-05745000468096</basicUdiDi>
    <tradeName>05745000468096</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030007</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468119</udiDi>
    <basicUdiDi>B-05745000468119</basicUdiDi>
    <tradeName>05745000468119</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG02001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468126</udiDi>
    <basicUdiDi>B-05745000468126</basicUdiDi>
    <tradeName>05745000468126</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PÄTAU SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030008</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468133</udiDi>
    <basicUdiDi>B-05745000468133</basicUdiDi>
    <tradeName>05745000468133</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PÄTAU SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030009</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468140</udiDi>
    <basicUdiDi>B-05745000468140</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030029</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468201</udiDi>
    <basicUdiDi>5745000468MFG010033FY</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010034</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468225</udiDi>
    <basicUdiDi>5745000468MFG010030FS</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010031</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468249</udiDi>
    <basicUdiDi>5745000468MFG010037G8</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010042</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468263</udiDi>
    <basicUdiDi>5745000468MFG010038GA</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010039</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:27.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468287</udiDi>
    <basicUdiDi>5745000468MFG010040FV</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010041</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:26.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468386</udiDi>
    <basicUdiDi>B-05745000468386</basicUdiDi>
    <tradeName>05745000468386</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030034, MFG030035</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:26.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468423</udiDi>
    <basicUdiDi>5745000468EU02000500019R</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0200050002 (PBC20A)</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:26.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468430</udiDi>
    <basicUdiDi>5745000468EU02000500019R</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0200050003 (PBC22)</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:26.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468447</udiDi>
    <basicUdiDi>5745000468EU02000500019R</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0200050004 (PBC22A)</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:26.723Z</lastUpdated>
  </row>
</eudamedExport>