<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000054349CR046GT</udiDi>
    <basicUdiDi>B-CNMF000054349CR046GT</basicUdiDi>
    <tradeName>Malaria Antibody Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Malaria Antibody Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:08:06.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR002G7</udiDi>
    <basicUdiDi>B-CNMF000054349CR002G7</basicUdiDi>
    <tradeName>Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:25.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908020139019</udiDi>
    <basicUdiDi>B-08908020139019</basicUdiDi>
    <tradeName>Truenat® Malaria Pv/Pf</tradeName>
    <deviceName>Truenat Malaria Pv/Pf</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601010025</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:11.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989330</udiDi>
    <basicUdiDi>B-08908007989330</basicUdiDi>
    <tradeName>Truenat Malaria Pv/Pf</tradeName>
    <deviceName>Truenat Malaria Pv/Pf</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601010050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:25.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989323</udiDi>
    <basicUdiDi>B-08908007989323</basicUdiDi>
    <tradeName>Truenat Malaria Pv/Pf</tradeName>
    <deviceName>Truenat Malaria Pv/Pf</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601010020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:23.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989316</udiDi>
    <basicUdiDi>B-08908007989316</basicUdiDi>
    <tradeName>Truenat® Malaria Pv/Pf</tradeName>
    <deviceName>Truenat Malaria Pv/Pf</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601010005, 601010020,601010025, 601010050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:20.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300638</udiDi>
    <basicUdiDi>B-08800204300638</basicUdiDi>
    <tradeName>08800204300638</tradeName>
    <deviceName>RADI Malaria Detection Kit</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:15:01.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300584</udiDi>
    <basicUdiDi>B-08800204300584</basicUdiDi>
    <tradeName>08800204300584</tradeName>
    <deviceName>CHAMP Malaria P.f Kit</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CB001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:50.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387213967</udiDi>
    <basicUdiDi>B-08684387213967</basicUdiDi>
    <tradeName>RevoDx Malaria qPCR Kit</tradeName>
    <deviceName>RevoDx Malaria qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202455-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:00:28.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387213950</udiDi>
    <basicUdiDi>B-08684387213950</basicUdiDi>
    <tradeName>RevoDx Malaria qPCR Kit</tradeName>
    <deviceName>RevoDx Malaria qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202455-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:00:27.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548259875</udiDi>
    <basicUdiDi>B-08683548259875</basicUdiDi>
    <tradeName>LyoSens Malaria Detection qPCR Kit</tradeName>
    <deviceName>Malaria Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO69</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:21:31.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698401744</udiDi>
    <basicUdiDi>B-06977698401744</basicUdiDi>
    <tradeName>Malaria Pf/Pan Antigen Rapid Test Cassette(Colloidal Gold)</tradeName>
    <deviceName>Malaria Pf/Pan Antigen Rapid Test Cassette(Colloidal Gold）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD034</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:20.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698401683</udiDi>
    <basicUdiDi>B-06977698401683</basicUdiDi>
    <tradeName>Malaria Pf Antigen Rapid Test Cassette(Colloidal Gold)</tradeName>
    <deviceName>Malaria Pf Antigen Rapid Test Cassette(Colloidal Gold)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD033</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:18.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753477588</udiDi>
    <basicUdiDi>B-06976753477588</basicUdiDi>
    <tradeName>Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KC003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:01:20.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753477540</udiDi>
    <basicUdiDi>B-06976753477540</basicUdiDi>
    <tradeName>Serum Amyloid A (SAA) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KC002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:01:18.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753474600</udiDi>
    <basicUdiDi>B-06976753474600</basicUdiDi>
    <tradeName>Malaria P.fP.v Rapid Test Device (whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A290901D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:10.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753474570</udiDi>
    <basicUdiDi>B-06976753474570</basicUdiDi>
    <tradeName>Malaria P.f.Pan Antigen Rapid Test Device (whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A280901D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:09.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753474549</udiDi>
    <basicUdiDi>B-06976753474549</basicUdiDi>
    <tradeName>Malaria P.f. Rapid Test Device (whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A270901D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:08.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854620667</udiDi>
    <basicUdiDi>B-06974854620667</basicUdiDi>
    <tradeName>JWF</tradeName>
    <deviceName>Malaria Ag P.f/Pan Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2201625</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:06.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854620643</udiDi>
    <basicUdiDi>B-06974854620643</basicUdiDi>
    <tradeName>Malaria Pf/Pv Ag Test Kit</tradeName>
    <deviceName>Malaria Pf/Pv Ag Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2201425</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:01.848Z</lastUpdated>
  </row>
</eudamedExport>