<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76490GA</udiDi>
    <basicUdiDi>B-DC76490GA</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>DC76035A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:27.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76489GR</udiDi>
    <basicUdiDi>B-DC76489GR</basicUdiDi>
    <tradeName>iStar-tTG IgG</tradeName>
    <deviceName>iStar-tTG 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>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76489</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:23.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76486GK</udiDi>
    <basicUdiDi>B-DC76486GK</basicUdiDi>
    <tradeName>iStar-tTG IgA</tradeName>
    <deviceName>iStar-tTG 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>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76486</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:22.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76485GH</udiDi>
    <basicUdiDi>B-DC76485GH</basicUdiDi>
    <tradeName>iStar-tTG IgA</tradeName>
    <deviceName>iStar-tTG 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>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76485</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:21.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76484GF</udiDi>
    <basicUdiDi>B-DC76484GF</basicUdiDi>
    <tradeName>iStar-tTG IgA</tradeName>
    <deviceName>iStar-tTG 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>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76484</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:22:21.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DMCA-R102acro8B</udiDi>
    <basicUdiDi>B-DMCA-R102acro8B</basicUdiDi>
    <tradeName>MCAT Rapid Test Cassette (Urine)</tradeName>
    <deviceName>MCAT 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>DMCA-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:12:24.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DKET100V2</udiDi>
    <basicUdiDi>B-DKET100V2</basicUdiDi>
    <tradeName>Ketamine Rapid Test</tradeName>
    <deviceName>Ketamine Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>DKET1001, DKET1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:12:22.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DGAB-1024F</udiDi>
    <basicUdiDi>B-DGAB-1024F</basicUdiDi>
    <tradeName>GAB Rapid Test  Cassette</tradeName>
    <deviceName>GAB 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>W0102080211</emdnCode>
    <emdnDescription>GABAPENTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGAB-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:12:21.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DFKE-ACOR1022Q</udiDi>
    <basicUdiDi>B-DFKE-ACOR1022Q</basicUdiDi>
    <tradeName>FKET Rapid Test Cassette (Urine)</tradeName>
    <deviceName>FKET 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>DFKE-ACOR102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:12:21.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DETO-ACOR102H4</udiDi>
    <basicUdiDi>B-DETO-ACOR102H4</basicUdiDi>
    <tradeName>Etomidate (ETO) Rapid Test (Urine)</tradeName>
    <deviceName>Etomidate (ETO) Rapid Test (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>DETO-ACOR102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:12:20.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MMprofilerAB</udiDi>
    <basicUdiDi>B-MMprofilerAB</basicUdiDi>
    <tradeName>MMprofiler</tradeName>
    <deviceName>MMprofiler</deviceName>
    <manufacturerName>SkylineDx B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>521181</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-13T10:04:15.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030127</udiDi>
    <basicUdiDi>B-00812101030127</basicUdiDi>
    <tradeName>ARK Meperidine Assay</tradeName>
    <deviceName>ARK Meperidine Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T07:54:05.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030134</udiDi>
    <basicUdiDi>B-00812101030134</basicUdiDi>
    <tradeName>ARK Meperidine Assay</tradeName>
    <deviceName>ARK Meperidine Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0001-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T07:54:05.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030141</udiDi>
    <basicUdiDi>B-00812101030141</basicUdiDi>
    <tradeName>ARK Meperidine Calibrator</tradeName>
    <deviceName>ARK Meperidine Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0002-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T07:54:05.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030158</udiDi>
    <basicUdiDi>B-00812101030158</basicUdiDi>
    <tradeName>ARK Meperidine Calibrator</tradeName>
    <deviceName>ARK Meperidine Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0002-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T07:54:05.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030165</udiDi>
    <basicUdiDi>B-00812101030165</basicUdiDi>
    <tradeName>ARK Meperidine Calibrator</tradeName>
    <deviceName>ARK Meperidine Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0002-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T07:54:05.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030172</udiDi>
    <basicUdiDi>B-00812101030172</basicUdiDi>
    <tradeName>ARK Meperidine Control</tradeName>
    <deviceName>ARK Meperidine Control</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152009</emdnCode>
    <emdnDescription>CONTROLS FOR NARCOTICS / TOXICOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0003-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T07:54:05.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814247020406</udiDi>
    <basicUdiDi>B-00814247020406</basicUdiDi>
    <tradeName>ROM Plus ES Complete Kit</tradeName>
    <deviceName>ROM Plus ES Complete Kit</deviceName>
    <manufacturerName>Clinical Innovations, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031386</manufacturerSrn>
    <authorisedRepresentativeName>MVF</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011189</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ROM-1025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-13T07:24:14.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-acrVPHLC69</udiDi>
    <basicUdiDi>B-acrVPHLC69</basicUdiDi>
    <tradeName>Vaginal pH Control</tradeName>
    <deviceName>Vaginal pH Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>acrVPHLC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:55:01.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-acrTV502R2W</udiDi>
    <basicUdiDi>B-acrTV502R2W</basicUdiDi>
    <tradeName>Trichomonas Vaginalis Rapid Test Cassette</tradeName>
    <deviceName>Trichomonas Vaginalis Rapid Test Cassette</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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>acrTV502R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:55:00.229Z</lastUpdated>
  </row>
</eudamedExport>