<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598017009</udiDi>
    <basicUdiDi>4050598IATUSASXN</basicUdiDi>
    <tradeName>IDK® Amino Extract (Stool sample preparation system filled with extraction buffer IDK® Amino Extract)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7999.RE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907990579439</udiDi>
    <basicUdiDi>59079905794smears4C</basicUdiDi>
    <tradeName>ILabU zestaw do samodzielnego pobierania wymazów z nosa, gardła i oka</tradeName>
    <deviceName>ILabU zestaw do samodzielnego pobierania wymazów z nosa, gardła i oka</deviceName>
    <manufacturerName>IlabU Sp. z o. o.</manufacturerName>
    <manufacturerSrn>PL-PR-000047472</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILW003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:35:14.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907990579422</udiDi>
    <basicUdiDi>59079905794geneticSL</basicUdiDi>
    <tradeName>ILabU zestaw do samodzielnego pobierania materiału genetycznego: nabłonek policzkowy</tradeName>
    <deviceName>ILabU zestaw do samodzielnego pobierania materiału genetycznego: nabłonek policzkowy</deviceName>
    <manufacturerName>IlabU Sp. z o. o.</manufacturerName>
    <manufacturerSrn>PL-PR-000047472</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILG001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:35:13.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907990579408</udiDi>
    <basicUdiDi>59079905794saliva29</basicUdiDi>
    <tradeName>ILabU zestaw do samodzielnego pobierania próbki: ślina</tradeName>
    <deviceName>ILabU zestaw do samodzielnego pobierania próbki: ślina</deviceName>
    <manufacturerName>IlabU Sp. z o. o.</manufacturerName>
    <manufacturerSrn>PL-PR-000047472</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILS004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:35:11.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468409</udiDi>
    <basicUdiDi>5745000468EU01001500019F</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>SeqHPV Test Self-sampling 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>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0100150001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:40:32.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468379</udiDi>
    <basicUdiDi>5745000468EU01001000017Q</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Cell-Free DNA Sampling 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>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0100100001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:40:31.813Z</lastUpdated>
  </row>
  <row>
    <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>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010028</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:40:21.422Z</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>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010043</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:40:19.810Z</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>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010037</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:40:15.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711276131002</udiDi>
    <basicUdiDi>5711276EasySamplerBASICX7</basicUdiDi>
    <tradeName>EasySampler Basic bulk</tradeName>
    <deviceName>EasySampler Basic</deviceName>
    <manufacturerName>GP Medical Devices A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000022391</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13 10 00</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:11:57.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>05608384014870</udiDi>
    <basicUdiDi>56083842800544Z</basicUdiDi>
    <tradeName>40ml</tradeName>
    <deviceName>ANAPAT Prefilled, contentores pré-cheios com Formol a 10% tamponado</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>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100500280054</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:33:56.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600236235235</udiDi>
    <basicUdiDi>5600236235AA007ED</basicUdiDi>
    <tradeName>SalivaGene® Swab Comfort</tradeName>
    <deviceName>SalivaGene® Swab Comfort</deviceName>
    <manufacturerName>ALS Life Sciences Portugal, S.A.</manufacturerName>
    <manufacturerSrn>PT-MF-000034751</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1035231100</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:15:26.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600236235228</udiDi>
    <basicUdiDi>5600236235AA006EB</basicUdiDi>
    <tradeName>SalivaGene® Collector</tradeName>
    <deviceName>SalivaGene® Collector</deviceName>
    <manufacturerName>ALS Life Sciences Portugal, S.A.</manufacturerName>
    <manufacturerSrn>PT-MF-000034751</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1035211200</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:15:22.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>05411967003747</udiDi>
    <basicUdiDi>5411967CD1B3</basicUdiDi>
    <tradeName>Blue Collect</tradeName>
    <deviceName>Blue Collect</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IB_CD01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:52:11.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>15061090190028</udiDi>
    <basicUdiDi>506109019HERKIT003YL</basicUdiDi>
    <tradeName>HER-KIT003</tradeName>
    <deviceName>HER-KIT</deviceName>
    <manufacturerName>Hertility Health</manufacturerName>
    <manufacturerSrn>UK-MF-000046710</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HER-KIT003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:22:22.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>05070003744015</udiDi>
    <basicUdiDi>50700037440DCNJC</basicUdiDi>
    <tradeName>Miscarriage Collection Cradle</tradeName>
    <deviceName>Miscarriage Collection Cradle</deviceName>
    <manufacturerName>Dignity Care Network Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000048837</manufacturerSrn>
    <authorisedRepresentativeName>IMed EUAR Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000045662</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>dcn001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:20:41.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065024320041</udiDi>
    <basicUdiDi>5065024320RectalMM</basicUdiDi>
    <tradeName>05065024320041</tradeName>
    <deviceName>SH24 STI Rectal Sample Collection Kit</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>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Maroon</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:18:31.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065024320010</udiDi>
    <basicUdiDi>5065024320ThroatSG</basicUdiDi>
    <tradeName>05065024320010</tradeName>
    <deviceName>SH24 STI Throat Sample Collection Kit</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>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Charcoal</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:18:29.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>15061090190004</udiDi>
    <basicUdiDi>506109019HERKIT001YG</basicUdiDi>
    <tradeName>HER-KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hertility Health</manufacturerName>
    <manufacturerSrn>UK-MF-000046710</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>HER-KIT001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:12:53.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061107470146</udiDi>
    <basicUdiDi>5061107470146RH</basicUdiDi>
    <tradeName>05061107470146</tradeName>
    <deviceName>Inuvi-006/CE Collection Kit</deviceName>
    <manufacturerName>Inuvi Health Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000057167</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Inuvi-006/CE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:09:08.026Z</lastUpdated>
  </row>
</eudamedExport>