<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-VD-D06aTF</udiDi>
    <basicUdiDi>B-VD-D06aTF</basicUdiDi>
    <tradeName>VD Test Kit FIA</tradeName>
    <deviceName>VD Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VD-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:15:08.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VD-D02aT3</udiDi>
    <basicUdiDi>B-VD-D02aT3</basicUdiDi>
    <tradeName>25-hydroxy Vitamin D Rapid Test</tradeName>
    <deviceName>25-hydroxy Vitamin D Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VD-D02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:15:06.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST0171DH</udiDi>
    <basicUdiDi>B-ST0171DH</basicUdiDi>
    <tradeName>Ferritin test kit (16 tests)</tradeName>
    <deviceName>Ferritin test kit (16 tests)</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0171</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:32:58.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST0170DF</udiDi>
    <basicUdiDi>B-ST0170DF</basicUdiDi>
    <tradeName>Ferritin test kit  (32 tests)</tradeName>
    <deviceName>Ferritin test kit  (32 tests)</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0170</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:32:57.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ImmuView_Put_LutP2</udiDi>
    <basicUdiDi>B-ImmuView_Put_LutP2</basicUdiDi>
    <tradeName>D-ImmuView_Put_LutP2</tradeName>
    <deviceName>ImmuView S. pneumoniae og L. pneumophila Urinary Antigen Test</deviceName>
    <manufacturerName>SSI Diagnostica A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023933</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95389</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:52.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ImmuView_PutMK</udiDi>
    <basicUdiDi>B-ImmuView_PutMK</basicUdiDi>
    <tradeName>ImmuView</tradeName>
    <deviceName>ImmuView S. pneumoniae Antigen Test</deviceName>
    <manufacturerName>SSI Diagnostica A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023933</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98748</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:50.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ImmuView_Lut_LutLW</udiDi>
    <basicUdiDi>B-ImmuView_Lut_LutLW</basicUdiDi>
    <tradeName>ImmuView</tradeName>
    <deviceName>ImmuView L. pneumophila and L. Longbeachae Urinary Antigen Test</deviceName>
    <manufacturerName>SSI Diagnostica A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023933</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98749</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:48.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000023735FW</udiDi>
    <basicUdiDi>B-DE-MF-000023735FW</basicUdiDi>
    <tradeName>D-DE-MF-000023735FW</tradeName>
    <deviceName>GlutenCHECK</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:11.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR009GM</udiDi>
    <basicUdiDi>B-CNMF000054349CR009GM</basicUdiDi>
    <tradeName>FOB Rapid Test Kit</tradeName>
    <deviceName>FOB Rapid Test Kit</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:33.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B66000UY</udiDi>
    <basicUdiDi>B-B66000UY</basicUdiDi>
    <tradeName>D-B66000UY</tradeName>
    <deviceName>NANOREPRO SARS-CoV-2 Antigen Schnelltest</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B66000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T21:00:23.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-924207QN</udiDi>
    <basicUdiDi>B-924207QN</basicUdiDi>
    <tradeName>DOMÁCÍ TEST Nesnášenlivost lepku</tradeName>
    <deviceName>DOMÁCÍ TEST Nesnášenlivost lepku [CZ] DOMÁCI TEST Neznášanlivosť lepku [SK]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>924207</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:22.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-924205QJ</udiDi>
    <basicUdiDi>B-924205QJ</basicUdiDi>
    <tradeName>ZELFTEST Glutenintolerantie</tradeName>
    <deviceName>ZELFTEST Glutenintolerantie [NL]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>924205</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:20.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-924203QE</udiDi>
    <basicUdiDi>B-924203QE</basicUdiDi>
    <tradeName>AUTO-TEST Intolerancia al gluten</tradeName>
    <deviceName>AUTO-TEST Intolerancia al gluten (ES) TESTE DE AUTODIAGNÓSTICO Intolerância ao glúten (PT)</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>924203</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:20.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-924202QC</udiDi>
    <basicUdiDi>B-924202QC</basicUdiDi>
    <tradeName>Veroval SELBT-TEST Gluten-Intoleranz</tradeName>
    <deviceName>Veroval SELBT-TEST Gluten-Intoleranz</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>924202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:18.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-924107QH</udiDi>
    <basicUdiDi>B-924107QH</basicUdiDi>
    <tradeName>Veroval DOMÁCÍ TEST Nedostatek železa</tradeName>
    <deviceName>Veroval DOMÁCÍ TEST Nedostatek železa [CZ] Veroval DOMÁCI TEST Nedostatok železa[PT]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>924107</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:16.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-924105QD</udiDi>
    <basicUdiDi>B-924105QD</basicUdiDi>
    <tradeName>Veroval  ZELFTEST IJzertekort</tradeName>
    <deviceName>Veroval  ZELFTEST IJzertekort [NL]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>924105</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:12.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-924103Q9</udiDi>
    <basicUdiDi>B-924103Q9</basicUdiDi>
    <tradeName>Veroval AUTO-TEST Deficiencia de hierro</tradeName>
    <deviceName>Veroval AUTO-TEST Deficiencia de hierro [ES]    Veroval  TESTE DE  AUTODIAGNÓSTICO Deficiência em ferro [PT]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>924103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:11.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-924102Q7</udiDi>
    <basicUdiDi>B-924102Q7</basicUdiDi>
    <tradeName>Veroval SELBT-TEST Eisenmangel</tradeName>
    <deviceName>Veroval SELBT-TEST Eisenmangel</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>924102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:10.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779028XXJY</udiDi>
    <basicUdiDi>B-84295779028XXJY</basicUdiDi>
    <tradeName>SIMPLE CD1WB</tradeName>
    <deviceName>SIMPLE CD1WB</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.028.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:57.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779029XZK9</udiDi>
    <basicUdiDi>B-84295779029XZK9</basicUdiDi>
    <tradeName>SIMPLE CD2WB</tradeName>
    <deviceName>SIMPLE CD2WB</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.029.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:55.391Z</lastUpdated>
  </row>
</eudamedExport>