<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06937339209573</udiDi>
    <basicUdiDi>B-06937339209573</basicUdiDi>
    <tradeName>Tuberculosis IgG/IgM Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VITB-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:44.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209542</udiDi>
    <basicUdiDi>B-06937339209542</basicUdiDi>
    <tradeName>Strep A Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIST-702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:39.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209399</udiDi>
    <basicUdiDi>B-06937339209399</basicUdiDi>
    <tradeName>S.pneumoniae Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090109</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VISP-102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:18.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209382</udiDi>
    <basicUdiDi>B-06937339209382</basicUdiDi>
    <tradeName>Typhoid IgG/IgM Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VITYb-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:16.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209351</udiDi>
    <basicUdiDi>B-06937339209351</basicUdiDi>
    <tradeName>C. difficile Toxin A/B+GDH Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VITG-637</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:12.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209245</udiDi>
    <basicUdiDi>B-06937339209245</basicUdiDi>
    <tradeName>Syphilis Control Solution (FIA)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC188-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:57.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209184</udiDi>
    <basicUdiDi>B-06937339209184</basicUdiDi>
    <tradeName>Syphilis Test Kit (FIA)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID188-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:48.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209153</udiDi>
    <basicUdiDi>B-06937339209153</basicUdiDi>
    <tradeName>H. pylori Antibody Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID82-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:44.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209146</udiDi>
    <basicUdiDi>B-06937339209146</basicUdiDi>
    <tradeName>H. pylori Antigen Test Kit ( FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID83-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:43.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339207531</udiDi>
    <basicUdiDi>B-06937339207531</basicUdiDi>
    <tradeName>C. difficile Toxin A/B Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VICT-627</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:07.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339207524</udiDi>
    <basicUdiDi>B-06937339207524</basicUdiDi>
    <tradeName>Streptococcus pneumoniae Ag Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090109</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VISP-102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:06.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339205889</udiDi>
    <basicUdiDi>B-06937339205889</basicUdiDi>
    <tradeName>Syphilis Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VISY-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:54:19.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339205872</udiDi>
    <basicUdiDi>B-06937339205872</basicUdiDi>
    <tradeName>S.pneumoniae/L.pneumoohila Combo Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSL-127</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:54:18.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339205841</udiDi>
    <basicUdiDi>B-06937339205841</basicUdiDi>
    <tradeName>H. pylori Ab Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIHP-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:54:13.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339205414</udiDi>
    <basicUdiDi>B-06937339205414</basicUdiDi>
    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIST-702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:54:04.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339204967</udiDi>
    <basicUdiDi>B-06937339204967</basicUdiDi>
    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIST-702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:32.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339204950</udiDi>
    <basicUdiDi>B-06937339204950</basicUdiDi>
    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIST-702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:31.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804597</udiDi>
    <basicUdiDi>B-06936155804597</basicUdiDi>
    <tradeName>Rapid Anti-TB (Mycobacterium Tuberculosis) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP09002-DS50</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:31.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804535</udiDi>
    <basicUdiDi>B-06936155804535</basicUdiDi>
    <tradeName>ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP03004-DS50</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:28.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804528</udiDi>
    <basicUdiDi>B-06936155804528</basicUdiDi>
    <tradeName>ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP03004-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:27.137Z</lastUpdated>
  </row>
</eudamedExport>