<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SAC2022012E5</udiDi>
    <basicUdiDi>B-SAC2022012E5</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>PV/PF Malaria pv(pLDH)/ pf(HRPⅡ) Antigen Test  (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022012</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:59.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022011E3</udiDi>
    <basicUdiDi>B-SAC2022011E3</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>PV/PF Malaria pv(pLDH)/ pf(HRPⅡ) Antigen Test  (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022011</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:59.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022010DZ</udiDi>
    <basicUdiDi>B-SAC2022010DZ</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>PV/PF Malaria pv(pLDH)/ pf(HRPⅡ) Antigen Test  (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022010</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:58.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022009EG</udiDi>
    <basicUdiDi>B-SAC2022009EG</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Malaria Pan/Pf Antigen Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022009</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:57.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022001DY</udiDi>
    <basicUdiDi>B-SAC2022001DY</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>PV/PF Malaria pv(pLDH)/ pf(HRPⅡ) Antigen Test  (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:44.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAL-D22bBY</udiDi>
    <basicUdiDi>B-MAL-D22bBY</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Rapid Test</tradeName>
    <deviceName>Malaria P.f./P.v. 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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-D22b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:08.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAL-D22aBW</udiDi>
    <basicUdiDi>B-MAL-D22aBW</basicUdiDi>
    <tradeName>Malaria P.f./P.an. Rapid Test</tradeName>
    <deviceName>Malaria P.f./P.an. 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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-D22a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:07.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MALAC1-023G</udiDi>
    <basicUdiDi>B-MALAC1-023G</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Rapid Test</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test</deviceName>
    <manufacturerName>Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020377</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MALAC1-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:06.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAL-D02aBL</udiDi>
    <basicUdiDi>B-MAL-D02aBL</basicUdiDi>
    <tradeName>Malaria P.f. Antigen Rapid Test</tradeName>
    <deviceName>Malaria P.f. 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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-D02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:49.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPV-R402K9</udiDi>
    <basicUdiDi>B-IMPV-R402K9</basicUdiDi>
    <tradeName>Malaria P.f. /P.v. Rapid Test Cassette</tradeName>
    <deviceName>Malaria P.f. /P.v. Rapid Test Cassette</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPV-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:39:15.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPN-401M8</udiDi>
    <basicUdiDi>B-IMPN-401M8</basicUdiDi>
    <tradeName>D-IMPN-401M8</tradeName>
    <deviceName>Malaria P.f./Pan Rapid Test Dipstick</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPN-401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:39:12.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPN-R402FZ</udiDi>
    <basicUdiDi>B-IMPN-R402FZ</basicUdiDi>
    <tradeName>Malaria P.f./Pan Rapid Test Cassette</tradeName>
    <deviceName>Malaria P.f./Pan Rapid Test Cassette</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPN-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:39:11.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMA-R402C3</udiDi>
    <basicUdiDi>B-IMA-R402C3</basicUdiDi>
    <tradeName>Malaria P.f. Rapid Test Cassette</tradeName>
    <deviceName>Malaria P.f. Rapid Test Cassette</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Alltest</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:38:40.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD160XG</udiDi>
    <basicUdiDi>B-GKPD160XG</basicUdiDi>
    <tradeName>Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD160</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:50.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD159XX</udiDi>
    <basicUdiDi>B-GKPD159XX</basicUdiDi>
    <tradeName>Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD159</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:48.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD114X9</udiDi>
    <basicUdiDi>B-GKPD114X9</basicUdiDi>
    <tradeName>Malaria P.f/P.v Ag Rapid Test Kit</tradeName>
    <deviceName>Malaria P.f/P.v Ag Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:26.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pvAb)-402aHG7N</udiDi>
    <basicUdiDi>B-GCMAL(pf/pvAb)-402aHG7N</basicUdiDi>
    <tradeName>Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)</tradeName>
    <deviceName>Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf/pv Ab)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:26.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pvAb)-402aAB</udiDi>
    <basicUdiDi>B-GCMAL(pf/pvAb)-402aAB</basicUdiDi>
    <tradeName>Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)</tradeName>
    <deviceName>Malaria Pf/Pv 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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf/pv Ab)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:26.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pvAb)-302aHG79</udiDi>
    <basicUdiDi>B-GCMAL(pf/pvAb)-302aHG79</basicUdiDi>
    <tradeName>Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf/pv Ab)-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:25.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pvAb)-302aA4</udiDi>
    <basicUdiDi>B-GCMAL(pf/pvAb)-302aA4</basicUdiDi>
    <tradeName>Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Malaria Pf/Pv Ab Rapid Test Cassette (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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf/pv Ab)-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:21.197Z</lastUpdated>
  </row>
</eudamedExport>