<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971760720078</udiDi>
    <basicUdiDi>B-06971760720078</basicUdiDi>
    <tradeName>06971760720078</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Qualitative Test</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</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>5 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:46:41.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971760720061</udiDi>
    <basicUdiDi>B-06971760720061</basicUdiDi>
    <tradeName>06971760720061</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Qualitative Test</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</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>1 test/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:46:40.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348761332</udiDi>
    <basicUdiDi>B-06971348761332</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-91-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:54.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348762506</udiDi>
    <basicUdiDi>B-06971348762506</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-129</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:53.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348761301</udiDi>
    <basicUdiDi>B-06971348761301</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-71-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:35.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348761080</udiDi>
    <basicUdiDi>B-06971348761080</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-91-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:34.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348761059</udiDi>
    <basicUdiDi>B-06971348761059</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-68-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:33.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348761042</udiDi>
    <basicUdiDi>B-06971348761042</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-68-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:29.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348760854</udiDi>
    <basicUdiDi>B-06971348760854</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-71</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:27.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348760755</udiDi>
    <basicUdiDi>B-06971348760755</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-69</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:27.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348760151</udiDi>
    <basicUdiDi>B-06971348760151</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-91-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:25.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225937331</udiDi>
    <basicUdiDi>B-06971225937331</basicUdiDi>
    <tradeName>Monkeypox Virus Real-time PCR Kit</tradeName>
    <deviceName>Monkeypox Virus Real-time PCR Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GPCR130024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:29:28.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225937225</udiDi>
    <basicUdiDi>B-06971225937225</basicUdiDi>
    <tradeName>Monkeypox Virus Real-time PCR Kit</tradeName>
    <deviceName>Monkeypox Virus Real-time PCR Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GPCR130048</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:29:28.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225936402</udiDi>
    <basicUdiDi>B-06971225936402</basicUdiDi>
    <tradeName>Monkeypox Virus Real-time PCR Kit</tradeName>
    <deviceName>Monkeypox Virus Real-time PCR Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GPCR130096</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:28:46.723Z</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>06936983126274</udiDi>
    <basicUdiDi>B-06936983126274</basicUdiDi>
    <tradeName>Dispositivo de Prueba Rápida para Chikungunya IgG/IgM</tradeName>
    <deviceName>Dispositivo de Prueba Rápida para Chikungunya IgG/IgM</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICHI-402</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:20:05.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983126212</udiDi>
    <basicUdiDi>B-06936983126212</basicUdiDi>
    <tradeName>Prueba Rápida de Mononucleosis en Casete</tradeName>
    <deviceName>Prueba Rápida de Mononucleosis en Casete</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>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMO-402</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:20:03.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987815005719</udiDi>
    <basicUdiDi>B-04987815005719</basicUdiDi>
    <tradeName>Capilia Flu Neo 10T/Box</tradeName>
    <deviceName>Capilia Flu Neo 10T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>CAFL0571</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:32.081Z</lastUpdated>
  </row>
</eudamedExport>