<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-522210N9</udiDi>
    <basicUdiDi>B-522210N9</basicUdiDi>
    <tradeName>D-522210N9</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52221001,52221005,52221020,52221025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:58:41.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-533212NX</udiDi>
    <basicUdiDi>B-533212NX</basicUdiDi>
    <tradeName>D-533212NX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53321201,53321205,53321220,53321225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:58:40.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-533211NV</udiDi>
    <basicUdiDi>B-533211NV</basicUdiDi>
    <tradeName>D-533211NV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53321101,53321105,53321120,53321125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:58:40.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-518328PY</udiDi>
    <basicUdiDi>B-518328PY</basicUdiDi>
    <tradeName>D-518328PY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51832801,51832810,51832825,51832800,51832802,51832803,51832804,51832806,51832821,51832831,51832845,51832823,51832811</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:52:23.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971100211396</udiDi>
    <basicUdiDi>B-06971100211396</basicUdiDi>
    <tradeName>06971100211396</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test</deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C320020005, A1C320020015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:08:25.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971100211389</udiDi>
    <basicUdiDi>B-06971100211389</basicUdiDi>
    <tradeName>06971100211389</tradeName>
    <deviceName>SARS-CoV-2/Influenza A/Influenza B Antigen Rapid Test</deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1A325020007, A1A325020019, A1A325020031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:08:24.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971100211372</udiDi>
    <basicUdiDi>B-06971100211372</basicUdiDi>
    <tradeName>06971100211372</tradeName>
    <deviceName>Influenza A/B Antigen Rapid Test</deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1A324020007，A1A324020019，A1A324020031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:08:20.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971100211365</udiDi>
    <basicUdiDi>B-06971100211365</basicUdiDi>
    <tradeName>06971100211365</tradeName>
    <deviceName>Diagnostic Kit for Calprotectin（Fluorescence  Immunochromatographic Assay）</deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</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>A1C205020001, A1C205020002, A1C205020003, A1C205020004, A1C205020005, A1C205020006, A1C205020007.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:08:19.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971100210917</udiDi>
    <basicUdiDi>B-06971100210917</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test(Colloidal Gold)</deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51332801</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:08:18.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971100210245</udiDi>
    <basicUdiDi>697110021E0083M</basicUdiDi>
    <tradeName>06971100210245</tradeName>
    <deviceName>Portable Immune Analyzer</deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2A010003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:37:08.026Z</lastUpdated>
  </row>
</eudamedExport>