<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974703168173</udiDi>
    <basicUdiDi>B-06974703168173</basicUdiDi>
    <tradeName>qLabs® ElectroMeter</tradeName>
    <deviceName>qLabs® ElectroMeter</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:33.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166513</udiDi>
    <basicUdiDi>B-06974703166513</basicUdiDi>
    <tradeName>mLabs® Multi-level CRP Controls</tradeName>
    <deviceName>mLabs® Multi-level CRP Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:32.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166469</udiDi>
    <basicUdiDi>B-06974703166469</basicUdiDi>
    <tradeName>mLabs® Multi-level NT-proBNP Controls</tradeName>
    <deviceName>mLabs® Multi-level NT-proBNP Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091013</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:31.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166452</udiDi>
    <basicUdiDi>B-06974703166452</basicUdiDi>
    <tradeName>mLabs® Multi-level Cardiac Panel 3 Controls</tradeName>
    <deviceName>mLabs® Multi-level Cardiac Panel 3 Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091012</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:30.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166445</udiDi>
    <basicUdiDi>B-06974703166445</basicUdiDi>
    <tradeName>mLabs® Multi-level PCT Controls</tradeName>
    <deviceName>mLabs® Multi-level PCT Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091009</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:26.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166438</udiDi>
    <basicUdiDi>B-06974703166438</basicUdiDi>
    <tradeName>mLabs® Multi-level BNP Controls</tradeName>
    <deviceName>mLabs® Multi-level BNP Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091008</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:26.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166421</udiDi>
    <basicUdiDi>B-06974703166421</basicUdiDi>
    <tradeName>mLabs® Multi-level TnI Controls</tradeName>
    <deviceName>mLabs® Multi-level TnI Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091007</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:25.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166414</udiDi>
    <basicUdiDi>B-06974703166414</basicUdiDi>
    <tradeName>mLabs® Multi-level D-Dimer Controls</tradeName>
    <deviceName>mLabs® Multi-level D-Dimer Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:24.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166377</udiDi>
    <basicUdiDi>B-06974703166377</basicUdiDi>
    <tradeName>mLabs® CRP</tradeName>
    <deviceName>mLabs® CRP</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091015</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:20.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166353</udiDi>
    <basicUdiDi>B-06974703166353</basicUdiDi>
    <tradeName>mLabs® Cardiac Panel 3</tradeName>
    <deviceName>mLabs® Cardiac Panel 3</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091011</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:19.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166346</udiDi>
    <basicUdiDi>B-06974703166346</basicUdiDi>
    <tradeName>mLabs® PCT</tradeName>
    <deviceName>mLabs® PCT</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091010</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:18.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166339</udiDi>
    <basicUdiDi>B-06974703166339</basicUdiDi>
    <tradeName>mLabs® NT-proBNP</tradeName>
    <deviceName>mLabs® NT-proBNP</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:18.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166308</udiDi>
    <basicUdiDi>B-06974703166308</basicUdiDi>
    <tradeName>mLabs® D-Dimer</tradeName>
    <deviceName>mLabs® D-Dimer</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:14.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166322</udiDi>
    <basicUdiDi>B-06974703166322</basicUdiDi>
    <tradeName>mLabs® BNP</tradeName>
    <deviceName>mLabs® BNP</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:13.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166315</udiDi>
    <basicUdiDi>B-06974703166315</basicUdiDi>
    <tradeName>mLabs® Troponin I</tradeName>
    <deviceName>mLabs® Troponin I</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:12.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703160795</udiDi>
    <basicUdiDi>B-06974703160795</basicUdiDi>
    <tradeName>qLabs® PT-INR Owren (Dry) Test Strips</tradeName>
    <deviceName>qLabs® PT-INR Owren (Dry) Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020801</emdnCode>
    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-2 Pro</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:11.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703160788</udiDi>
    <basicUdiDi>B-06974703160788</basicUdiDi>
    <tradeName>qLabs® PT-INR Owren (Dry) Test Strips</tradeName>
    <deviceName>qLabs® PT-INR Owren (Dry) Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020801</emdnCode>
    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:55.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703160764</udiDi>
    <basicUdiDi>B-06974703160764</basicUdiDi>
    <tradeName>qLabs® Multi-level Coag Controls</tradeName>
    <deviceName>qLabs® Multi-level Coag Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-6-CL Pro</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:54.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703160757</udiDi>
    <basicUdiDi>B-06974703160757</basicUdiDi>
    <tradeName>qLabs® Coag Panel 4 Test Strips</tradeName>
    <deviceName>qLabs® Coag Panel 4 Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020899</emdnCode>
    <emdnDescription>HAEMOSTASIS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-6 Pro</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:53.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703160269</udiDi>
    <basicUdiDi>B-06974703160269</basicUdiDi>
    <tradeName>qLabs® FIB Test Strips</tradeName>
    <deviceName>qLabs® FIB Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020899</emdnCode>
    <emdnDescription>HAEMOSTASIS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-18 Pro</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:50.803Z</lastUpdated>
  </row>
</eudamedExport>