<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05065024320393</udiDi>
    <basicUdiDi>5065024320RectalMM</basicUdiDi>
    <tradeName>05065024320393</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SH24 Digital Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000048864</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ivory</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:14:18.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>05608384014894</udiDi>
    <basicUdiDi>56083842800544Z</basicUdiDi>
    <tradeName>120ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ESTERIPLAS- PRODUTOS PARA A AREA DA SAUDE, LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000033228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100500280056</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T17:55:13.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>05608384014900</udiDi>
    <basicUdiDi>56083842800544Z</basicUdiDi>
    <tradeName>250ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ESTERIPLAS- PRODUTOS PARA A AREA DA SAUDE, LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000033228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>FIXING REAGENTS (HISTOLOGY/CYTOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100500280057</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T17:55:13.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>05608384014917</udiDi>
    <basicUdiDi>56083842800544Z</basicUdiDi>
    <tradeName>500ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ESTERIPLAS- PRODUTOS PARA A AREA DA SAUDE, LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000033228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>FIXING REAGENTS (HISTOLOGY/CYTOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100500280058</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T17:55:13.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>05608384014924</udiDi>
    <basicUdiDi>56083842800544Z</basicUdiDi>
    <tradeName>1000ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ESTERIPLAS- PRODUTOS PARA A AREA DA SAUDE, LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000033228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100500280059</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T17:55:13.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000026</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OGD-500.001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000132</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OGD-510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000248</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OGD-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000255</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OGD-610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000583</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OG-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000590</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OG-510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000613</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OG-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000620</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene ONE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ON-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000637</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene ONE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ON-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000651</udiDi>
    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OG-610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000798</udiDi>
    <basicUdiDi>0627595F0600GX</basicUdiDi>
    <tradeName>OMNIgene ORAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OME-505.005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026130095</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 without barcode (VCPZ26)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ26</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026165400</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 (VCPZ27)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026190976</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 without barcode (VCPZ30)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026190983</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 without barcode (VCPZ31)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.039Z</lastUpdated>
  </row>
</eudamedExport>