<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952804817657</udiDi>
    <basicUdiDi>B-06952804817657</basicUdiDi>
    <tradeName>Syphilis Rapid Test</tradeName>
    <deviceName>Syphilis Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYP-P11 SYP-P23 SYP-W11 SYP-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:39.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816681</udiDi>
    <basicUdiDi>B-06952804816681</basicUdiDi>
    <tradeName>H. pylori Antibodies Rapid Test</tradeName>
    <deviceName>H. pylori Antibodies Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-P11 HP-P23 HP-W11 HP-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:28.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804811174</udiDi>
    <basicUdiDi>B-06952804811174</basicUdiDi>
    <tradeName>S. pneumoniae Rapid Test Device (Urine)</tradeName>
    <deviceName>Streptococcus Pneumoniae Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPN-U23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:18.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804811167</udiDi>
    <basicUdiDi>B-06952804811167</basicUdiDi>
    <tradeName>Legionella Antigen Rapid Test Device (Urine)</tradeName>
    <deviceName>Legionella Urinary Antigen test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEG-U23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:16.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804810672</udiDi>
    <basicUdiDi>B-06952804810672</basicUdiDi>
    <tradeName>Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Tuberculosis Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-W23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:26:58.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804809720</udiDi>
    <basicUdiDi>69528048A463101ZT</basicUdiDi>
    <tradeName>Strep A Rapid Test Device</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A46310120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:26:51.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803841</udiDi>
    <basicUdiDi>B-06952804803841</basicUdiDi>
    <tradeName>H. pylori Antibody FIA</tradeName>
    <deviceName>H. pylori Antibody FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:26:12.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803834</udiDi>
    <basicUdiDi>B-06952804803834</basicUdiDi>
    <tradeName>Syphilis FIA</tradeName>
    <deviceName>Syphilis FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYP-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:26:10.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803827</udiDi>
    <basicUdiDi>B-06952804803827</basicUdiDi>
    <tradeName>C. difficile GDH FIA</tradeName>
    <deviceName>C. difficile GDH FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDH-F23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:57.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803780</udiDi>
    <basicUdiDi>B-06952804803780</basicUdiDi>
    <tradeName>H. pylori Antigen FIA</tradeName>
    <deviceName>H. pylori Antigen FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-F23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:55.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803612</udiDi>
    <basicUdiDi>B-06952804803612</basicUdiDi>
    <tradeName>06952804803612</tradeName>
    <deviceName>Cryptococcus Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:21.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803605</udiDi>
    <basicUdiDi>B-06952804803605</basicUdiDi>
    <tradeName>06952804803605</tradeName>
    <deviceName>Giardia lamblia Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL-F23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:11.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802899</udiDi>
    <basicUdiDi>B-06952804802899</basicUdiDi>
    <tradeName>STA FIA</tradeName>
    <deviceName>STA FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-S23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:25.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996053938</udiDi>
    <basicUdiDi>B-06950996053938</basicUdiDi>
    <tradeName>Strep A Rapid Test Cassette (Throat Swab)</tradeName>
    <deviceName>Strep A Rapid Test Cassette (Throat Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSTR-502a</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:34:01.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996025713</udiDi>
    <basicUdiDi>B-06950996025713</basicUdiDi>
    <tradeName>Strep A Rapid Test Strip (Throat Swab)</tradeName>
    <deviceName>Strep A Rapid Test Strip (Throat Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSTR-501a</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:34.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002363</udiDi>
    <basicUdiDi>B-06950996002363</basicUdiDi>
    <tradeName>Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSYP-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:27.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983104456</udiDi>
    <basicUdiDi>6970277510000EXK</basicUdiDi>
    <tradeName>H. pylori Antibody Rapid Test</tradeName>
    <deviceName></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 Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-N402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:13.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983104470</udiDi>
    <basicUdiDi>6970277510000FXM</basicUdiDi>
    <tradeName>Syphilis Rapid Test</tradeName>
    <deviceName></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 Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISY-N402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:13.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983104487</udiDi>
    <basicUdiDi>6970277510000FXM</basicUdiDi>
    <tradeName>Syphilis Rapid Test</tradeName>
    <deviceName></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 Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISY-N402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:13.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983104661</udiDi>
    <basicUdiDi>6970277510000JXV</basicUdiDi>
    <tradeName>H. pylori Antigen Rapid Test</tradeName>
    <deviceName></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 Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-N602-20</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:12.891Z</lastUpdated>
  </row>
</eudamedExport>