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<eudamedExport entity="devices">
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    <udiDi>05745000468300</udiDi>
    <basicUdiDi>5745000468MFG010028G7</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>DNA Sample Storage Card</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010028</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:08.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468294</udiDi>
    <basicUdiDi>5745000468MFG010043G3</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Stool Sample Collection Kit for Colorectal Cancer Testing</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010043</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:08.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468270</udiDi>
    <basicUdiDi>5745000468MFG010040FV</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Sample Pretreatment Kit for Methylation Detection</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010040</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:07.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468256</udiDi>
    <basicUdiDi>5745000468MFG010038GA</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>DNA Isolation Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010038</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:06.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468232</udiDi>
    <basicUdiDi>5745000468MFG010037G8</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Stool Sample Collection Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010037</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:05.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468218</udiDi>
    <basicUdiDi>5745000468MFG010030FS</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010030</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:04.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468195</udiDi>
    <basicUdiDi>5745000468MFG010033FY</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010033</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:04.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468188</udiDi>
    <basicUdiDi>5745000468MFG010035G4</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010035</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:03.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468171</udiDi>
    <basicUdiDi>5745000468MFG010019G6</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010019</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:02.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468164</udiDi>
    <basicUdiDi>5745000468HKM910001MS</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Non-Invasive Fetal Trisomy (NIFTY) Test Sample Collection Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HKM910001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:01.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468157</udiDi>
    <basicUdiDi>5745000468BGISEQ-500PX</basicUdiDi>
    <tradeName>05745000468157</tradeName>
    <deviceName>sequencing system</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGISEQ-500</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:05:00.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468102</udiDi>
    <basicUdiDi>5745000468MFG010010FL</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Universal Reaction Kit for Sequencing (Combinatorial Probe-Anchor Synthesis Sequencing Method)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010010</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:04:58.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468089</udiDi>
    <basicUdiDi>5745000468MFG010011FN</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Kit</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010011</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:04:57.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003510146</udiDi>
    <basicUdiDi>574400351EU0200080001RZ</basicUdiDi>
    <tradeName>05744003510146</tradeName>
    <deviceName>Liquid Chromatography Tandem Mass Spectrometer</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0200080001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:04:15.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003510139</udiDi>
    <basicUdiDi>574400351EU0200070001RN</basicUdiDi>
    <tradeName>05744003510139</tradeName>
    <deviceName>Inherited Metabolic Sample (Liquid Chromatography-Tandem Mass Spectrometry) Pretreatment System</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0200070001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:04:14.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003510061</udiDi>
    <basicUdiDi>B-05744003510061</basicUdiDi>
    <tradeName>05744003510061</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>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030024; MFG030025</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003510085</udiDi>
    <basicUdiDi>B-05744003510085</basicUdiDi>
    <tradeName>05744003510085</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>/</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003510344</udiDi>
    <basicUdiDi>B-05744003510344</basicUdiDi>
    <tradeName>05744003510344</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>MFG030051</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003510375</udiDi>
    <basicUdiDi>B-05744003510375</basicUdiDi>
    <tradeName>05744003510375</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>MFG030057</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003510382</udiDi>
    <basicUdiDi>B-05744003510382</basicUdiDi>
    <tradeName>05744003510382</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>MFG020007</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.281Z</lastUpdated>
  </row>
</eudamedExport>