<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-VILP-426SD</udiDi>
    <basicUdiDi>B-VILP-426SD</basicUdiDi>
    <tradeName>Leptospira IgG/IgM Rapid Test</tradeName>
    <deviceName>Leptospira IgG/IgM 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VILP-426</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:50.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VILEG-101HD</udiDi>
    <basicUdiDi>B-VILEG-101HD</basicUdiDi>
    <tradeName>Legionella Pneumophila Rapid Test</tradeName>
    <deviceName>Legionella Pneumophila 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>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VILEG-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:45.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIHP-401Q9</udiDi>
    <basicUdiDi>B-VIHP-401Q9</basicUdiDi>
    <tradeName>H. pylori Ag Rapid Test</tradeName>
    <deviceName>H. pylori Ag 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>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIHP-401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:44.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TYP-D02aW5</udiDi>
    <basicUdiDi>B-TYP-D02aW5</basicUdiDi>
    <tradeName>Typhoid Antibody Rapid Test</tradeName>
    <deviceName>Typhoid Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP-D02a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:24:35.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TE40B/S-GZ-40BTG</udiDi>
    <basicUdiDi>B-TE40B/S-GZ-40BTG</basicUdiDi>
    <tradeName>Tetanos Quick Stick</tradeName>
    <deviceName>Tetanos Quick Stick</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE40B / S-GZ-40B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:08.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TE-50UA9</udiDi>
    <basicUdiDi>B-TE-50UA9</basicUdiDi>
    <tradeName>Tetanos Quick Stick</tradeName>
    <deviceName>Tetanos Quick Stick</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE-50U</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:07.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TB-D22aRH</udiDi>
    <basicUdiDi>B-TB-D22aRH</basicUdiDi>
    <tradeName>Tuberculosis (TB) IgG/IgM Rapid Test</tradeName>
    <deviceName>Tuberculosis (TB) IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-D22a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:53.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SYP-D02aVJ</udiDi>
    <basicUdiDi>B-SYP-D02aVJ</basicUdiDi>
    <tradeName>Syphilis Antibody Rapid Test</tradeName>
    <deviceName>Syphilis Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYP-D02a, SYP-D01a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:46:33.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-STB-K02aNQ</udiDi>
    <basicUdiDi>B-STB-K02aNQ</basicUdiDi>
    <tradeName>Strep B Antigen Rapid Test</tradeName>
    <deviceName>Strep B Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STB-K02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:45:47.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-STA-B02bLE</udiDi>
    <basicUdiDi>B-STA-B02bLE</basicUdiDi>
    <tradeName>Strep A Antigen Rapid Test</tradeName>
    <deviceName>Strep A Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-B02b</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:45:45.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RICK-W23PR</udiDi>
    <basicUdiDi>B-RICK-W23PR</basicUdiDi>
    <tradeName>D-RICK-W23PR</tradeName>
    <deviceName>Rickettsia 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>RICK-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:38.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MI-F42002N4</udiDi>
    <basicUdiDi>B-MI-F42002N4</basicUdiDi>
    <tradeName>D-MI-F42002N4</tradeName>
    <deviceName>Crypto/Giardia combo 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>2026-07-14T02:07:30.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L031-10627J4</udiDi>
    <basicUdiDi>B-L031-10627J4</basicUdiDi>
    <tradeName>Quik-Check</tradeName>
    <deviceName>Quik-Check Syphilis Rapid Test Cassette (Serum/Plasma/Whole Blood)</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L031-10627</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:48:16.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L031-10445HU</udiDi>
    <basicUdiDi>B-L031-10445HU</basicUdiDi>
    <tradeName>Flowflex</tradeName>
    <deviceName>Flowflex Syphilis Rapid Test Cassette (Serum/Plasma/Whole Blood)</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L031-10445</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:48:11.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IrHPG6009G</udiDi>
    <basicUdiDi>B-IrHPG6009G</basicUdiDi>
    <tradeName>H.pylori Antigen Rapid Test Cassette (Feces)</tradeName>
    <deviceName>H.pylori Antigen Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IrHPG6002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:17:19.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITB-402SL</udiDi>
    <basicUdiDi>B-ITB-402SL</basicUdiDi>
    <tradeName>D-ITB-402SL</tradeName>
    <deviceName>TB Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITB-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:43:16.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISY-U401RL</udiDi>
    <basicUdiDi>B-ISY-U401RL</basicUdiDi>
    <tradeName>D-ISY-U401RL</tradeName>
    <deviceName>Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISY-U401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:43:02.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISY-8032V</udiDi>
    <basicUdiDi>B-ISY-8032V</basicUdiDi>
    <tradeName>D-ISY-8032V</tradeName>
    <deviceName>Syphilis Rapid Test (Oral Fluid)</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISY-803</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:43:01.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IST-502YJ</udiDi>
    <basicUdiDi>B-IST-502YJ</basicUdiDi>
    <tradeName>D-IST-502YJ</tradeName>
    <deviceName>Strep A Rapid Test Device (Throat Swab)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:57.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IST-501YG</udiDi>
    <basicUdiDi>B-IST-501YG</basicUdiDi>
    <tradeName>D-IST-501YG</tradeName>
    <deviceName>Strep A Rapid Test Strip (Throat Swab)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:56.855Z</lastUpdated>
  </row>
</eudamedExport>