<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DBPF-ACO102RW</udiDi>
    <basicUdiDi>B-DBPF-ACO102RW</basicUdiDi>
    <tradeName>Buprofezin (BPF) rapid Test</tradeName>
    <deviceName>Buprofezin (BPF) rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBPF-ACO102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:42:57.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DBPF-ACO101RU</udiDi>
    <basicUdiDi>B-DBPF-ACO101RU</basicUdiDi>
    <tradeName>Buprofezin (BPF) rapid Test</tradeName>
    <deviceName>Buprofezin (BPF) rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBPF-ACO101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:42:53.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAR-ACO114R7</udiDi>
    <basicUdiDi>B-DAR-ACO114R7</basicUdiDi>
    <tradeName>Arecoline (ARC) Rapid Test</tradeName>
    <deviceName>Arecoline (ARC) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAR-ACO114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:42:52.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAR-ACO102QY</udiDi>
    <basicUdiDi>B-DAR-ACO102QY</basicUdiDi>
    <tradeName>Arecoline (ARC) Rapid Test</tradeName>
    <deviceName>Arecoline (ARC) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAR-ACO102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:42:51.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAR-ACO101QW</udiDi>
    <basicUdiDi>B-DAR-ACO101QW</basicUdiDi>
    <tradeName>Arecoline (ARC) Rapid Test</tradeName>
    <deviceName>Arecoline (ARC) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAR-ACO101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:42:50.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAMT-ACO114XD</udiDi>
    <basicUdiDi>B-DAMT-ACO114XD</basicUdiDi>
    <tradeName>Amitriptyline (AMTL) Rapid Test</tradeName>
    <deviceName>Amitriptyline (AMTL) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAMT-ACO114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:42:46.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAMT-ACO102X6</udiDi>
    <basicUdiDi>B-DAMT-ACO102X6</basicUdiDi>
    <tradeName>Amitriptyline (AMTL) Rapid Test</tradeName>
    <deviceName>Amitriptyline (AMTL) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAMT-ACO102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:42:45.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAMT-ACO101X4</udiDi>
    <basicUdiDi>B-DAMT-ACO101X4</basicUdiDi>
    <tradeName>Amitriptyline (AMTL) Rapid Test</tradeName>
    <deviceName>Amitriptyline (AMTL) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAMT-ACO101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:42:45.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250693</udiDi>
    <basicUdiDi>B-06974490250693</basicUdiDi>
    <tradeName>Activated Partial Thromboplastin Time (APTT) Reagent(Ellagic Acid)</tradeName>
    <deviceName>Activated Partial Thromboplastin Time (APTT) Reagent(Ellagic Acid)</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-APTT-1000E</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:37.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250631</udiDi>
    <basicUdiDi>B-06974490250631</basicUdiDi>
    <tradeName>Fibrinogen Reference Plasma</tradeName>
    <deviceName>Fibrinogen Reference Plasma</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-FIB-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:37.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250600</udiDi>
    <basicUdiDi>B-06974490250600</basicUdiDi>
    <tradeName>Antithrombin III Assay Kit</tradeName>
    <deviceName>Antithrombin III Assay Kit</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020602</emdnCode>
    <emdnDescription>ANTITHROMBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ci-AT-24</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:36.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250556</udiDi>
    <basicUdiDi>B-06974490250556</basicUdiDi>
    <tradeName>活化部分凝血活酶时间检测试剂盒(鞣花酸凝固法)</tradeName>
    <deviceName>活化部分凝血活酶时间检测试剂盒(鞣花酸凝固法)</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ci-APTT-10E</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:32.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250495</udiDi>
    <basicUdiDi>B-06974490250495</basicUdiDi>
    <tradeName>Fibrin Degradation Product (FDP) Control</tradeName>
    <deviceName>Fibrin Degradation Product (FDP) Control</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDPII-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:31.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250587</udiDi>
    <basicUdiDi>B-06974490250587</basicUdiDi>
    <tradeName>Fibrin Degradation Product (FDP) Assay Kit</tradeName>
    <deviceName>Fibrin Degradation Product (FDP) Assay Kit</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ci-FDP-10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:30.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250570</udiDi>
    <basicUdiDi>B-06974490250570</basicUdiDi>
    <tradeName>D-Dimer Assay Kit</tradeName>
    <deviceName>D-Dimer Assay Kit</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ci-DD-24</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:29.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250488</udiDi>
    <basicUdiDi>B-06974490250488</basicUdiDi>
    <tradeName>Fibrin Degradation Product (FDP) Control</tradeName>
    <deviceName>Fibrin Degradation Product (FDP) Control</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDPI-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:12.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250471</udiDi>
    <basicUdiDi>B-06974490250471</basicUdiDi>
    <tradeName>D-Dimer Control</tradeName>
    <deviceName>D-Dimer Control</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDII-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:12.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250464</udiDi>
    <basicUdiDi>B-06974490250464</basicUdiDi>
    <tradeName>D-Dimer Control</tradeName>
    <deviceName>D-Dimer Control</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATIII-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:11.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250457</udiDi>
    <basicUdiDi>B-06974490250457</basicUdiDi>
    <tradeName>D-Dimer Assay Kit</tradeName>
    <deviceName>D-Dimer Assay Kit</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ci-DD-12</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:10.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250433</udiDi>
    <basicUdiDi>B-06974490250433</basicUdiDi>
    <tradeName>Coagulation Control Plasma</tradeName>
    <deviceName>Coagulation Control Plasma</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONP-II-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:06.567Z</lastUpdated>
  </row>
</eudamedExport>