<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00608337001518</udiDi>
    <basicUdiDi>B-00608337001518</basicUdiDi>
    <tradeName>OraQuick HIV Self-Test</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Spain/Portugal</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0601U</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:28.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>00608337001273</udiDi>
    <basicUdiDi>B-00608337001273</basicUdiDi>
    <tradeName>OraQuick HIV Self-Test</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, UK</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0600U</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:27.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>00608337001068</udiDi>
    <basicUdiDi>B-00608337001068</basicUdiDi>
    <tradeName>OraQuick SAMOTEST NA HIV</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Slovakia/Czech</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0630U</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:26.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>00608337000566</udiDi>
    <basicUdiDi>B-00608337000566</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test, Pouched Device</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001-2141</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:25.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>00608337000528</udiDi>
    <basicUdiDi>B-00608337000528</basicUdiDi>
    <tradeName>OraQuick® HCV Rapid Antibody Test Kit Controls</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test Kit Controls</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0278</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:21.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-801016NM</udiDi>
    <basicUdiDi>B-801016NM</basicUdiDi>
    <tradeName>TEST AUTODIAGNOSTICO HELICOBACTER PYLORI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:45:36.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-101177LK</udiDi>
    <basicUdiDi>B-101177LK</basicUdiDi>
    <tradeName>Test autodiagnostico Celiachia</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101177-x</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:42:35.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908020139637</udiDi>
    <basicUdiDi>890802013964456</basicUdiDi>
    <tradeName>STABILYSE Prep Free</tradeName>
    <deviceName>STABILYSE Prep Free</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90101PF20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:08.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989972</udiDi>
    <basicUdiDi>8908007989972DA</basicUdiDi>
    <tradeName>Trueprep® AUTO v2</tradeName>
    <deviceName>Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603042001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:19.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989965</udiDi>
    <basicUdiDi>8908007989965DD</basicUdiDi>
    <tradeName>Truelab® Quattro</tradeName>
    <deviceName>Truelab® Quattro Real Time Quantitative micro PCR Analyzer</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603023001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:18.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989958</udiDi>
    <basicUdiDi>8908007989958DG</basicUdiDi>
    <tradeName>Truelab® Duo</tradeName>
    <deviceName>Truelab® Duo Real Time Quantitative micro PCR Analyzer</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603022001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:18.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989941</udiDi>
    <basicUdiDi>8908007989941CX</basicUdiDi>
    <tradeName>Truelab® Uno Dx</tradeName>
    <deviceName>Truelab® Uno Dx Real Time Quantitative micro PCR Analyzer</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:14.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989927</udiDi>
    <basicUdiDi>89080201395835B</basicUdiDi>
    <tradeName>Trueprep AUTO Universal Sample Pre-treatment Pack</tradeName>
    <deviceName>Trueprep AUTO Universal Sample Pre-treatment Pack</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60205AB20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:13.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989903</udiDi>
    <basicUdiDi>89080201395765E</basicUdiDi>
    <tradeName>Trueprep AUTO MTB Sample Pre-treatment Pack</tradeName>
    <deviceName>Trueprep AUTO MTB Sample Pre treatment Pack</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60204AS20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:12.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989880</udiDi>
    <basicUdiDi>8908007989880D4</basicUdiDi>
    <tradeName>Trueprep AUTO Universal Cartridge Based Sample Prep Kit</tradeName>
    <deviceName>Trueprep® AUTO Universal Cartridge Based Sample Prep Kit</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60203AR25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:11.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989866</udiDi>
    <basicUdiDi>890802013959058</basicUdiDi>
    <tradeName>Trueprep AUTO Transport Medium for Swab Specimen Pack</tradeName>
    <deviceName>Trueprep AUTO Transport Medium for Swab Specimen Pack</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05020199</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60206TS20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:06.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989859</udiDi>
    <basicUdiDi>8908007989859DD</basicUdiDi>
    <tradeName>Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit</tradeName>
    <deviceName>Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60207AR50</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:06.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>18881300626010</udiDi>
    <basicUdiDi>8881300626ODONASSISTU2</basicUdiDi>
    <tradeName>OdonAssist</tradeName>
    <deviceName>OdonAssist</deviceName>
    <manufacturerName>Maternal Newborn Health Innovations Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000035955</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U1004</emdnCode>
    <emdnDescription>MANUAL OBSTETRICAL EXTRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-126</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:10:35.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649997674011</udiDi>
    <basicUdiDi>7649997674VSZ5</basicUdiDi>
    <tradeName>VENUS SHELL</tradeName>
    <deviceName>VENUS SHELL</deviceName>
    <manufacturerName>HeroSupport</manufacturerName>
    <manufacturerSrn>CH-MF-000051519</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011280</emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:56:10.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649988168413</udiDi>
    <basicUdiDi>76499881684RetinaWiseRL</basicUdiDi>
    <tradeName>07649988168413</tradeName>
    <deviceName>retinaWISE</deviceName>
    <manufacturerName>Oculox Technologies SA</manufacturerName>
    <manufacturerSrn>CH-MF-000038775</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A001-007-v03</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:49:15.925Z</lastUpdated>
  </row>
</eudamedExport>