<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>G4581150001ST</udiDi>
    <basicUdiDi>B-G4581150001ST</basicUdiDi>
    <tradeName>Malaria Antigen Test Card</tradeName>
    <deviceName>Malaria Antigen Test Card</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1150 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-21T03:01:47.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458294001VN</udiDi>
    <basicUdiDi>B-G458294001VN</basicUdiDi>
    <tradeName>Phosphorus UV (Single Reagent)</tradeName>
    <deviceName>Phosphorus UV (Single Reagent)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>294 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-19T11:01:59.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-06971808258853WJ</udiDi>
    <basicUdiDi>B-06971808258853WJ</basicUdiDi>
    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>TERC gene amplification probe detection kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-013</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-18T07:00:35.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984062129</udiDi>
    <basicUdiDi>B-06975984062129</basicUdiDi>
    <tradeName>ß-THALASSAEMIA &amp; HbA1c Control Material</tradeName>
    <deviceName>ß-THALASSAEMIA &amp; HbA1c Control Material</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320200701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-16T19:00:20.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115902610</udiDi>
    <basicUdiDi>B-08809115902610</basicUdiDi>
    <tradeName>HemoCue HbA1c 501 Analyzer</tradeName>
    <deviceName>HemoCue HbA1c 501 Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405210</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-15T19:00:16.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458516300309K</udiDi>
    <basicUdiDi>B-G458516300309K</basicUdiDi>
    <tradeName>Cardiac Troponin I Rapid Test Cassette (serum/plasma/whole blood)</tradeName>
    <deviceName>Cardiac Troponin I Rapid Test Cassette (serum/plasma/whole blood)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>516 30 030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-15T11:01:32.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>G4583930013P</udiDi>
    <basicUdiDi>B-G4583930013P</basicUdiDi>
    <tradeName>25-OH Vitamin D Calibrator Set</tradeName>
    <deviceName>25-OH Vitamin D Calibrator Set</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152206</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>393 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-15T11:01:31.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCNB-R102acro8B</udiDi>
    <basicUdiDi>B-DCNB-R102acro8B</basicUdiDi>
    <tradeName>CNB Rapid Test Cassette (Urine)</tradeName>
    <deviceName>CNB Rapid Test Cassette (Urine)</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>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCNB-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:45.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCNB-1027L</udiDi>
    <basicUdiDi>B-DCNB-1027L</basicUdiDi>
    <tradeName>CNB Rapid Test Cassette</tradeName>
    <deviceName>CNB Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCNB-102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:45.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCIT-ACOR1028S</udiDi>
    <basicUdiDi>B-DCIT-ACOR1028S</basicUdiDi>
    <tradeName>CIT Rapid Test Cassette (Urine)</tradeName>
    <deviceName>CIT Rapid Test Cassette (Urine)</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>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCIT-ACOR102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:42.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCFY-R102acroME</udiDi>
    <basicUdiDi>B-DCFY-R102acroME</basicUdiDi>
    <tradeName>Carfentanyl (CFYL) Rapid Test Cassette (Urine)</tradeName>
    <deviceName>Carfentanyl (CFYL) Rapid Test Cassette (Urine)</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>DCFY-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:41.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCC01654</udiDi>
    <basicUdiDi>B-DCC01654</basicUdiDi>
    <tradeName>Inhibin B Control</tradeName>
    <deviceName>Inhibin B Control</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCC016</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:41.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCAR100PY</udiDi>
    <basicUdiDi>B-DCAR100PY</basicUdiDi>
    <tradeName>Carisoprodol Rapid Test</tradeName>
    <deviceName>Carisoprodol Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</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>DCAR1001, DCAR1002, DCAR1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:40.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCAR-R102acroA8</udiDi>
    <basicUdiDi>B-DCAR-R102acroA8</basicUdiDi>
    <tradeName>Carisoprodol Rapid Test Cassette (Urine)</tradeName>
    <deviceName>Carisoprodol Rapid Test Cassette (Urine)</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>DCAR-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:36.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCA-R102acroLQ</udiDi>
    <basicUdiDi>B-DCA-R102acroLQ</basicUdiDi>
    <tradeName>CAT Rapid Test Cassette (Urine)</tradeName>
    <deviceName>CAT Rapid Test Cassette (Urine)</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>DCA-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:35.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76495GL</udiDi>
    <basicUdiDi>B-DC76495GL</basicUdiDi>
    <tradeName>iStar-DGP IgG</tradeName>
    <deviceName>iStar-DGP IgG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76495</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:34.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76494GJ</udiDi>
    <basicUdiDi>B-DC76494GJ</basicUdiDi>
    <tradeName>iStar-DGP IgG</tradeName>
    <deviceName>iStar-DGP IgG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76494</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:33.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76493GG</udiDi>
    <basicUdiDi>B-DC76493GG</basicUdiDi>
    <tradeName>iStar-DGP IgG</tradeName>
    <deviceName>iStar-DGP IgG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76493</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:29.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76492GE</udiDi>
    <basicUdiDi>B-DC76492GE</basicUdiDi>
    <tradeName>iStar-DGP IgA</tradeName>
    <deviceName>iStar-DGP IgA</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76492</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:29.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76491GC</udiDi>
    <basicUdiDi>B-DC76491GC</basicUdiDi>
    <tradeName>iStar-DGP IgA</tradeName>
    <deviceName>iStar-DGP IgA</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76491</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:28.304Z</lastUpdated>
  </row>
</eudamedExport>