<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936155804504</udiDi>
    <basicUdiDi>B-06936155804504</basicUdiDi>
    <tradeName>Rapid Dengue Duo (NS1 Ag &amp; IgM/IgG Ab) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP71004-TC20</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:23.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804498</udiDi>
    <basicUdiDi>B-06936155804498</basicUdiDi>
    <tradeName>Rapid Dengue Duo (NS1 Ag &amp; IgM/IgG Ab) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP71004-TC10</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:22.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804481</udiDi>
    <basicUdiDi>B-06936155804481</basicUdiDi>
    <tradeName>Rapid Dengue Duo (NS1 Ag &amp; IgM/IgG Ab) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP71004-TC1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:21.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804474</udiDi>
    <basicUdiDi>B-06936155804474</basicUdiDi>
    <tradeName>One Step Dengue NS1 Ag Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP71003-TC40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:19.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804467</udiDi>
    <basicUdiDi>B-06936155804467</basicUdiDi>
    <tradeName>ONE STEP Anti-Dengue (IgM &amp; IgG) Tri-line Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP71002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:18.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804443</udiDi>
    <basicUdiDi>B-06936155804443</basicUdiDi>
    <tradeName>Rapid FOB Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP13001-DS50</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:17.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804382</udiDi>
    <basicUdiDi>B-06936155804382</basicUdiDi>
    <tradeName>ONE STEP Malaria(p.f/p.v) Tri-line Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP11003-TC25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:16.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804375</udiDi>
    <basicUdiDi>B-06936155804375</basicUdiDi>
    <tradeName>ONE STEP Malaria(p.f.) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP11002-TC40</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:15.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804351</udiDi>
    <basicUdiDi>B-06936155804351</basicUdiDi>
    <tradeName>06936155804351</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP02153-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:13.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804344</udiDi>
    <basicUdiDi>B-06936155804344</basicUdiDi>
    <tradeName>06936155804344</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP02153-TC10</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:12.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804337</udiDi>
    <basicUdiDi>B-06936155804337</basicUdiDi>
    <tradeName>06936155804337</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP02152-TC40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:11.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804320</udiDi>
    <basicUdiDi>B-06936155804320</basicUdiDi>
    <tradeName>06936155804320</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP02152-TC25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:10.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804313</udiDi>
    <basicUdiDi>B-06936155804313</basicUdiDi>
    <tradeName>06936155804313</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP01153-TC40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:09.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804306</udiDi>
    <basicUdiDi>B-06936155804306</basicUdiDi>
    <tradeName>06936155804306</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP01153-TC10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:07.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804290</udiDi>
    <basicUdiDi>B-06936155804290</basicUdiDi>
    <tradeName>06936155804290</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP01152-TC40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:05.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804283</udiDi>
    <basicUdiDi>B-06936155804283</basicUdiDi>
    <tradeName>06936155804283</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP01152-TC25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:04.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155803958</udiDi>
    <basicUdiDi>B-06936155803958</basicUdiDi>
    <tradeName>ONE STEP Tricyclic Antidepressants (TCA) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP06011-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:03.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155803934</udiDi>
    <basicUdiDi>B-06936155803934</basicUdiDi>
    <tradeName>ONE STEP Methamphetamine (MET) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP06005-TC40</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:01.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155803927</udiDi>
    <basicUdiDi>B-06936155803927</basicUdiDi>
    <tradeName>ONE STEP Methadone (MTD) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP06008-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:00.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155803910</udiDi>
    <basicUdiDi>B-06936155803910</basicUdiDi>
    <tradeName>ONE STEP Ketamine (KAN) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP06012-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:12:59.430Z</lastUpdated>
  </row>
</eudamedExport>