<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCMAL(pf/pv)-402aTT</udiDi>
    <basicUdiDi>B-GCMAL(pf/pv)-402aTT</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)</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)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:20.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pv)-402aHGG2</udiDi>
    <basicUdiDi>B-GCMAL(pf/pv)-402aHGG2</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)</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)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:19.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pan)-402aHGAD</udiDi>
    <basicUdiDi>B-GCMAL(pf/pan)-402aHGAD</basicUdiDi>
    <tradeName>Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)</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/pan)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:18.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pan)-402aBS</udiDi>
    <basicUdiDi>B-GCMAL(pf/pan)-402aBS</basicUdiDi>
    <tradeName>Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)</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/pan)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:14.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf)-402a83</udiDi>
    <basicUdiDi>B-GCMAL(pf)-402a83</basicUdiDi>
    <tradeName>Malaria P.f. Ag Rapid Test Casssette (Whole Blood)</tradeName>
    <deviceName>Malaria P.f. Ag Rapid Test Casssette (Whole Blood)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:14.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pan)-402aHG2H</udiDi>
    <basicUdiDi>B-GCMAL(pan)-402aHG2H</basicUdiDi>
    <tradeName>Malaria Pan Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Malaria Pan Ag Rapid Test Cassette (Whole Blood)</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(pan)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:13.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pan)-402aAX</udiDi>
    <basicUdiDi>B-GCMAL(pan)-402aAX</basicUdiDi>
    <tradeName>Malaria Pan Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Malaria Pan Ag Rapid Test Cassette (Whole Blood)</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(pan)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:12.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(Pf)-402aHGKG</udiDi>
    <basicUdiDi>B-GCMAL(Pf)-402aHGKG</basicUdiDi>
    <tradeName>Malaria Pf Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Malaria Pf Ag Rapid Test Cassette (Whole Blood)</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)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:57.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M706221FF</udiDi>
    <basicUdiDi>B-G2M706221FF</basicUdiDi>
    <tradeName>Malaria-Q Real-Time PCR Kit</tradeName>
    <deviceName>Malaria-Q Real-Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M706221, G2M706221R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:50.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B99VL</udiDi>
    <basicUdiDi>B-ABT-IDT-B99VL</basicUdiDi>
    <tradeName>Accu-Tell®Malaria P.f./Pan Cassette(Whole Blood)</tradeName>
    <deviceName>Accu-Tell® Rapid Malaria P.f. /Pan Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B99</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:29.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B85V9</udiDi>
    <basicUdiDi>B-ABT-IDT-B85V9</basicUdiDi>
    <tradeName>Accu-Tell® Malaria P.f. Cassette(Whole Blood)</tradeName>
    <deviceName>Accu-Tell® Malaria P.f. Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B85</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:25.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A99VF</udiDi>
    <basicUdiDi>B-ABT-IDT-A99VF</basicUdiDi>
    <tradeName>Accu-Tell®Malaria P.f./Pan Strip(Whole Blood)</tradeName>
    <deviceName>Accu-Tell® Rapid Malaria P.f. /Pan Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A99</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:16.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-472038N-25AT</udiDi>
    <basicUdiDi>B-472038N-25AT</basicUdiDi>
    <tradeName>NADAL® Malaria Pf/Pan Ag 4 Species Test</tradeName>
    <deviceName>NADAL Malaria Pf/Pan Ag 4 Species Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</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>472038N-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:36.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600903</udiDi>
    <basicUdiDi>B-16972698600903</basicUdiDi>
    <tradeName>Malaria Pf/Pv Antigen Rapid Test Device</tradeName>
    <deviceName>Malaria Pf/Pv Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</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>P231108</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:51:49.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600897</udiDi>
    <basicUdiDi>B-16972698600897</basicUdiDi>
    <tradeName>Malaria Pf Antigen Rapid Test Device</tradeName>
    <deviceName>Malaria Pf Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</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>P231107</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:51:48.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600910</udiDi>
    <basicUdiDi>B-16972698600910</basicUdiDi>
    <tradeName>Malaria Pf/Pan Antigen Rapid Test Device</tradeName>
    <deviceName>Malaria Pf/Pan Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</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>P231109</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:51:46.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763112</udiDi>
    <basicUdiDi>B-15065023763112</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Malaria Pf Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</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>TV10012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:09.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763105</udiDi>
    <basicUdiDi>B-15065023763105</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Malaria Pf /Pv Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</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>TV10011</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:08.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763099</udiDi>
    <basicUdiDi>B-15065023763099</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Malaria Pf /Pan Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</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>TV10010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:08.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616718</udiDi>
    <basicUdiDi>B-08697962616718</basicUdiDi>
    <tradeName>SOFTEC Malaria P.f/P.v Rapid Test Kit</tradeName>
    <deviceName>Malaria P.f/P.v Rapid Test Kit</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</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>SFMPFPV</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:06.390Z</lastUpdated>
  </row>
</eudamedExport>