<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05407007960422</udiDi>
    <basicUdiDi>B-05407007960422</basicUdiDi>
    <tradeName>UltraGene Assay SARS-CoV-2 Universalis</tradeName>
    <deviceName>UltraGene Assay SARS-CoV-2 Universalis V2.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>169B50</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:09:08.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960293</udiDi>
    <basicUdiDi>B-05407007960293</basicUdiDi>
    <tradeName>ViroScore® - HIV Software</tradeName>
    <deviceName>ViroScore® - HIV Software</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-09-014</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:08:57.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960286</udiDi>
    <basicUdiDi>B-05407007960286</basicUdiDi>
    <tradeName>DeepChek® - HSV Software</tradeName>
    <deviceName>DeepChek® - HSV Software</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-12-023 (SM)</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:08:46.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960279</udiDi>
    <basicUdiDi>B-05407007960279</basicUdiDi>
    <tradeName>DeepChek® - HPV Software</tradeName>
    <deviceName>DeepChek® - HPV Software</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-12-023 (PM)</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:08:35.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960262</udiDi>
    <basicUdiDi>B-05407007960262</basicUdiDi>
    <tradeName>DeepChek® - HIV Software</tradeName>
    <deviceName>DeepChek® - HIV Software</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-12-023 (HM)</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:08:32.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960255</udiDi>
    <basicUdiDi>B-05407007960255</basicUdiDi>
    <tradeName>DeepChek® - HCV Software</tradeName>
    <deviceName>DeepChek® - HCV Software</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-12-023 (CM)</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:08:21.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960248</udiDi>
    <basicUdiDi>B-05407007960248</basicUdiDi>
    <tradeName>DeepChek® - HBV Software</tradeName>
    <deviceName>DeepChek® - HBV Software</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-12-023 (BM)</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:08:09.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960231</udiDi>
    <basicUdiDi>B-05407007960231</basicUdiDi>
    <tradeName>DeepChek® - CMV Software</tradeName>
    <deviceName>DeepChek® - CMV Software</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-12-023 (MM)</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:07:58.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960224</udiDi>
    <basicUdiDi>B-05407007960224</basicUdiDi>
    <tradeName>BacterioChek® - TB Software</tradeName>
    <deviceName>BacterioChek® - TB Software</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-12-023 (TM)</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:07:54.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960033</udiDi>
    <basicUdiDi>B-05407007960033</basicUdiDi>
    <tradeName>DeepChek® Assay INTEGRASE Sequencing</tradeName>
    <deviceName>DeepChek® Assay INTEGRASE Sequencing V1.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030108</emdnCode>
    <emdnDescription>HIV 1 GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>126A24</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:07:43.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960026</udiDi>
    <basicUdiDi>B-05407007960026</basicUdiDi>
    <tradeName>DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Sequencing</tradeName>
    <deviceName>DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Sequencing V1.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030108</emdnCode>
    <emdnDescription>HIV 1 GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>125A24</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:07:27.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960019</udiDi>
    <basicUdiDi>B-05407007960019</basicUdiDi>
    <tradeName>DeepChek® Assay INTEGRASE Genotyping and Drug Resistance</tradeName>
    <deviceName>DeepChek® Assay INTEGRASE Genotyping and Drug Resistance V1.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030108</emdnCode>
    <emdnDescription>HIV 1 GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>122A24</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:07:20.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960002</udiDi>
    <basicUdiDi>B-05407007960002</basicUdiDi>
    <tradeName>DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Genotyping and Drug Resistance</tradeName>
    <deviceName>DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Genotyping and Drug Resistance V1.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030108</emdnCode>
    <emdnDescription>HIV 1 GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121A24</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:07:12.777Z</lastUpdated>
  </row>
</eudamedExport>