<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06977903340813</udiDi>
    <basicUdiDi>B-06977903340813</basicUdiDi>
    <tradeName>06977903340813</tradeName>
    <deviceName>Malaria Pf/Pan Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110403C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:16.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752408</udiDi>
    <basicUdiDi>B-06976374752408</basicUdiDi>
    <tradeName>Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold）</tradeName>
    <deviceName>Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR045-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:44:11.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752392</udiDi>
    <basicUdiDi>B-06976374752392</basicUdiDi>
    <tradeName>Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold）</tradeName>
    <deviceName>Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR045-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:44:10.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763026</udiDi>
    <basicUdiDi>B-06976202763026</basicUdiDi>
    <tradeName>Malaria Pf/Pan Ag 4 Species Rapid Test</tradeName>
    <deviceName>Malaria Pf/Pan Ag 4 Species Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIMAL4-942</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:49.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762944</udiDi>
    <basicUdiDi>B-06976202762944</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Rapid Test</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIMALfv-922</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:29.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762739</udiDi>
    <basicUdiDi>B-06976202762739</basicUdiDi>
    <tradeName>Malaria P.f./P.v./Pan Rapid Test</tradeName>
    <deviceName>Malaria P.f./P.v./Pan Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIMP-932</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:04.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762722</udiDi>
    <basicUdiDi>B-06976202762722</basicUdiDi>
    <tradeName>Malaria P.f./Pan Rapid Test</tradeName>
    <deviceName>Malaria P.f./Pan Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIMALfa-922</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:03.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762715</udiDi>
    <basicUdiDi>B-06976202762715</basicUdiDi>
    <tradeName>Malaria P.f. Rapid Test</tradeName>
    <deviceName>Malaria P.f. Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIMALf-902</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:00.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201414</udiDi>
    <basicUdiDi>B-06975166201414</basicUdiDi>
    <tradeName>06975166201414</tradeName>
    <deviceName>Malaria Pf/Pv Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:03:00.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201407</udiDi>
    <basicUdiDi>B-06975166201407</basicUdiDi>
    <tradeName>06975166201407</tradeName>
    <deviceName>Malaria Pf/Pv Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:59.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201391</udiDi>
    <basicUdiDi>B-06975166201391</basicUdiDi>
    <tradeName>06975166201391</tradeName>
    <deviceName>Malaria Pf/Pv Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:58.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201384</udiDi>
    <basicUdiDi>B-06975166201384</basicUdiDi>
    <tradeName>06975166201384</tradeName>
    <deviceName>Malaria Pf/Pv Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 Test/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:54.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201377</udiDi>
    <basicUdiDi>B-06975166201377</basicUdiDi>
    <tradeName>06975166201377</tradeName>
    <deviceName>Malaria Pf/Pan Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:54.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201360</udiDi>
    <basicUdiDi>B-06975166201360</basicUdiDi>
    <tradeName>06975166201360</tradeName>
    <deviceName>Malaria Pf/Pan Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:53.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201353</udiDi>
    <basicUdiDi>B-06975166201353</basicUdiDi>
    <tradeName>06975166201353</tradeName>
    <deviceName>Malaria Pf/Pan Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:52.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201346</udiDi>
    <basicUdiDi>B-06975166201346</basicUdiDi>
    <tradeName>06975166201346</tradeName>
    <deviceName>Malaria Pf/Pan Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 Test/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:37.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201339</udiDi>
    <basicUdiDi>B-06975166201339</basicUdiDi>
    <tradeName>06975166201339</tradeName>
    <deviceName>Malaria Pf Histidine-Rich Protein II Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:36.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201322</udiDi>
    <basicUdiDi>B-06975166201322</basicUdiDi>
    <tradeName>06975166201322</tradeName>
    <deviceName>Malaria Pf Histidine-Rich Protein II Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:32.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201315</udiDi>
    <basicUdiDi>B-06975166201315</basicUdiDi>
    <tradeName>06975166201315</tradeName>
    <deviceName>Malaria Pf Histidine-Rich Protein II Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:31.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201308</udiDi>
    <basicUdiDi>B-06975166201308</basicUdiDi>
    <tradeName>06975166201308</tradeName>
    <deviceName>Malaria Pf Histidine-Rich Protein II Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 Test/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:30.813Z</lastUpdated>
  </row>
</eudamedExport>