<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-YJC10301NW-50TW9</udiDi>
    <basicUdiDi>B-YJC10301NW-50TW9</basicUdiDi>
    <tradeName>Avian Influenza Virus (H5/H7/H9) Real Time PCR Kit</tradeName>
    <deviceName>Avian Influenza Virus (H5/H7/H9) Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040515</emdnCode>
    <emdnDescription>AVIAN INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJC10301NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:03:28.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJC10301NW-25TW9</udiDi>
    <basicUdiDi>B-YJC10301NW-25TW9</basicUdiDi>
    <tradeName>Avian Influenza Virus (H5/H7/H9) Real Time PCR Kit</tradeName>
    <deviceName>Avian Influenza Virus (H5/H7/H9) Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040515</emdnCode>
    <emdnDescription>AVIAN INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJC10301NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:03:27.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJC10128NW-50TZQ</udiDi>
    <basicUdiDi>B-YJC10128NW-50TZQ</basicUdiDi>
    <tradeName>SARS-CoV Real Time PCR Kit</tradeName>
    <deviceName>SARS-CoV Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJC10128NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:03:26.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJC10128NW-25TZQ</udiDi>
    <basicUdiDi>B-YJC10128NW-25TZQ</basicUdiDi>
    <tradeName>SARS-CoV Real Time PCR Kit</tradeName>
    <deviceName>SARS-CoV Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJC10128NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:03:25.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHATOCOVFLUF9</udiDi>
    <basicUdiDi>B-WHATOCOVFLUF9</basicUdiDi>
    <tradeName>D-WHATOCOVFLUF9</tradeName>
    <deviceName>COVID-19/FluA+B Antigen Combo Rapid Test</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-AT-OCOVFLU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:49.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHATOCOVAgAbhP9</udiDi>
    <basicUdiDi>B-WHATOCOVAgAbhP9</basicUdiDi>
    <tradeName>D-WHATOCOVAgAbhP9</tradeName>
    <deviceName>COVID-19 Ag and IgG/IgM Ab(High Sensitivity) Combo Rapid Test</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-AT-OCOVAgAbh</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:48.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHATOCOVAgAbYA</udiDi>
    <basicUdiDi>B-WHATOCOVAgAbYA</basicUdiDi>
    <tradeName>D-WHATOCOVAgAbYA</tradeName>
    <deviceName>COVID-19 Ag and IgG/IgM Ab Combo Rapid Test</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-AT-OCOVAgAb</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:47.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHATOCOVAg08UJ</udiDi>
    <basicUdiDi>B-WHATOCOVAg08UJ</basicUdiDi>
    <tradeName>WH Accu Test®</tradeName>
    <deviceName>WH Accu Test® SARS-CoV-2 Antigen Test</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHATOCOV080202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:46.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHATOCOVAg01U4</udiDi>
    <basicUdiDi>B-WHATOCOVAg01U4</basicUdiDi>
    <tradeName>First Sign®</tradeName>
    <deviceName>First Sign® SARS-CoV-2 Antigen Test</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-AT-OCOV010202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:42.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WELL22-16AG2R</udiDi>
    <basicUdiDi>B-WELL22-16AG2R</basicUdiDi>
    <tradeName>SARS-CoV-2 Ag Rapid Test</tradeName>
    <deviceName>VivaDiag Wellion SARS-CoV-2 Ag Rapid Test, lct, article number</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WELL22-16AG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:41.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WELL22-16AB2F</udiDi>
    <basicUdiDi>B-WELL22-16AB2F</basicUdiDi>
    <tradeName>IgM/IgG Rapid Test</tradeName>
    <deviceName>VivaDiag Wellion IgM/IgG Rapid Test, lct, article number</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WELL22-16AB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:40.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VLD0136</udiDi>
    <basicUdiDi>B-VLD0136</basicUdiDi>
    <tradeName>SARS-CoV-2/Flu A/FIu B Ag</tradeName>
    <deviceName>SARS-CoV-2/Flu A/FIu BAg Rapid Test VLD01-03-13</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VLD01-03-13</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:22.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID3532</udiDi>
    <basicUdiDi>B-VID3532</basicUdiDi>
    <tradeName>COVID-19 IgM/IgG / SARS-CoV-2 IgM/IgG</tradeName>
    <deviceName>COVID-19 IgM/IgG Rapid Test / SARS-CoV-2 IgM/IgG Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID35</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:40.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID133EU</udiDi>
    <basicUdiDi>B-VID133EU</basicUdiDi>
    <tradeName>VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA)</tradeName>
    <deviceName>VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID133-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:39.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID112EL</udiDi>
    <basicUdiDi>B-VID112EL</basicUdiDi>
    <tradeName>VivaDiag Rotavirus/Adenovirus Test Kit (FIA)</tradeName>
    <deviceName>VivaDiag Rotavirus/Adenovirus Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID112-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:08.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCD18ZM</udiDi>
    <basicUdiDi>B-VCD18ZM</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCD18</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:25.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405nCoVTRT5K9</udiDi>
    <basicUdiDi>B-TRMF000028405nCoVTRT5K9</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP 2019-nCoV Triple Detection Kit v3, 500T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nCoVT-RT500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:40.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405nCoVRT50FZ</udiDi>
    <basicUdiDi>B-TRMF000028405nCoVRT50FZ</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP 2019-nCoV (2019-nCoV) Detection Kit v3, 500T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nCoV-RT500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:39.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MPRT50SP</udiDi>
    <basicUdiDi>B-TRMF000028405MPRT50SP</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP Monkeypox PCR Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:47.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405HPVGRT50MX</udiDi>
    <basicUdiDi>B-TRMF000028405HPVGRT50MX</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP HPV HR &amp; 6 /11 Genotyping Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPVG-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:34.441Z</lastUpdated>
  </row>
</eudamedExport>