<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-400444MK</udiDi>
    <basicUdiDi>B-400444MK</basicUdiDi>
    <tradeName>CeliacDetect</tradeName>
    <deviceName>CeliacDetect (EN/ES/IT/POL)</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>400444</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:38.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-400350M9</udiDi>
    <basicUdiDi>B-400350M9</basicUdiDi>
    <tradeName>ZuhauseTEST Zöliakie</tradeName>
    <deviceName>ZuhauseTEST Zöliakie [DE/EN/FR/ESP]</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>400350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:33.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-400251M6</udiDi>
    <basicUdiDi>B-400251M6</basicUdiDi>
    <tradeName>Mivolis Schnelltest Zöliakie</tradeName>
    <deviceName>Mivolis Schnelltest Zöliakie</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>400251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:33.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-400250M4</udiDi>
    <basicUdiDi>B-400250M4</basicUdiDi>
    <tradeName>ZuhauseTEST Zöliakie</tradeName>
    <deviceName>ZuhauseTEST Zöliakie</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>400250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:32.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-360660PG</udiDi>
    <basicUdiDi>B-360660PG</basicUdiDi>
    <tradeName>FerritinCHECK</tradeName>
    <deviceName>FerritinCHECK [BG/EN]</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>360660</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:58.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-360610NZ</udiDi>
    <basicUdiDi>B-360610NZ</basicUdiDi>
    <tradeName>RapiChek FerritinTEST</tradeName>
    <deviceName>RapiChek FerritinTEST (HU/EN/RO/PL)</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>360610</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:57.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-360400NL</udiDi>
    <basicUdiDi>B-360400NL</basicUdiDi>
    <tradeName>FerritinCHECK</tradeName>
    <deviceName>FerritinCHECK [DE/EN/FR/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>360400</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:39.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-360270NX</udiDi>
    <basicUdiDi>B-360270NX</basicUdiDi>
    <tradeName>FerritinCHECK</tradeName>
    <deviceName>FerritinCHECK  [EN/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>360270</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:38.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-360200NA</udiDi>
    <basicUdiDi>B-360200NA</basicUdiDi>
    <tradeName>ZuhauseTEST Eisenmangel</tradeName>
    <deviceName>ZuhauseTEST 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>360200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:36.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-360100N5</udiDi>
    <basicUdiDi>B-360100N5</basicUdiDi>
    <tradeName>FerritinCHECK</tradeName>
    <deviceName>FerritinCHECK</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>360100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:32.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975783510033</udiDi>
    <basicUdiDi>B-16975783510033</basicUdiDi>
    <tradeName>Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit ( Latex microspheres Assay )</tradeName>
    <deviceName>Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit ( Latex microspheres Assay )</deviceName>
    <manufacturerName>Ningbo Beautiful Life Medical Biotechnology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002185</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>NBMLRS-XG-S6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:09:44.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975783510026</udiDi>
    <basicUdiDi>B-16975783510026</basicUdiDi>
    <tradeName>16975783510026</tradeName>
    <deviceName>COVID-19 Antigen Test Kit (Colloidal Gold Assay)</deviceName>
    <manufacturerName>Ningbo Beautiful Life Medical Biotechnology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002185</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>NBMLRS-XG-S5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:08:12.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975783510019</udiDi>
    <basicUdiDi>B-16975783510019</basicUdiDi>
    <tradeName>Saliva SARS-CoV-2 (2019-nCoV) Antigen Test Kit（Nanocarbon Assay）</tradeName>
    <deviceName>Saliva SARS-CoV-2 (2019-nCoV) Antigen Test Kit（Nanocarbon Assay）</deviceName>
    <manufacturerName>Ningbo Beautiful Life Medical Biotechnology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002185</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>NBMLRS-XG-S2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:08:10.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285188161</udiDi>
    <basicUdiDi>B-08693285188161</basicUdiDi>
    <tradeName>08693285188161</tradeName>
    <deviceName>Procalcitonin Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</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>TIPCT03</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:51.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285187515</udiDi>
    <basicUdiDi>B-08693285187515</basicUdiDi>
    <tradeName>08693285187515</tradeName>
    <deviceName>Procalcitonin Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</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>IPCT02025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:33:29.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285187508</udiDi>
    <basicUdiDi>B-08693285187508</basicUdiDi>
    <tradeName>08693285187508</tradeName>
    <deviceName>Procalcitonin Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</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>RTPCT02025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:33:10.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285187492</udiDi>
    <basicUdiDi>B-08693285187492</basicUdiDi>
    <tradeName>08693285187492</tradeName>
    <deviceName>Procalcitonin Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</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>TPCT02025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:33:10.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285186143</udiDi>
    <basicUdiDi>B-08693285186143</basicUdiDi>
    <tradeName>08693285186143</tradeName>
    <deviceName>Procalcitonin Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</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>RTPCT02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:30:43.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285186129</udiDi>
    <basicUdiDi>B-08693285186129</basicUdiDi>
    <tradeName>08693285186129</tradeName>
    <deviceName>Procalcitonin Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</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>IPCT02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:30:42.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285186112</udiDi>
    <basicUdiDi>B-08693285186112</basicUdiDi>
    <tradeName>08693285186112</tradeName>
    <deviceName>Procalcitonin Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</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>TPCT02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:30:42.022Z</lastUpdated>
  </row>
</eudamedExport>