<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04033145206699</udiDi>
    <basicUdiDi>4987026TD-LFMFYZ</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pf Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>978000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:05.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145206682</udiDi>
    <basicUdiDi>4987026TD-LFMV24</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pv Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>975000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:01.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145191407</udiDi>
    <basicUdiDi>4987026TD-LFMPZM</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pan Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>974000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:30:59.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMA-401PC</udiDi>
    <basicUdiDi>B-IMA-401PC</basicUdiDi>
    <tradeName>Malaria P.f. Rapid Test Dipstick</tradeName>
    <deviceName>Malaria P.f. Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMA-401</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:09:20.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPV-402Q2</udiDi>
    <basicUdiDi>B-IMPV-402Q2</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>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPV-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:40.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPN-402MA</udiDi>
    <basicUdiDi>B-IMPN-402MA</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>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPN-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:39.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMA-402PE</udiDi>
    <basicUdiDi>B-IMA-402PE</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>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:38.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-MAL-435QF</udiDi>
    <basicUdiDi>B-FI-MAL-435QF</basicUdiDi>
    <tradeName>Malaria P.f./P.v. /Pan Test Cassette</tradeName>
    <deviceName>Malaria P.f./P.v. /Pan Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-MAL-435</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:27.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145206705</udiDi>
    <basicUdiDi>4987026TD-LFMPZM</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pan Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>977000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T06:26:46.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIRE589010H</udiDi>
    <basicUdiDi>B-+ENTIRE589010H</basicUdiDi>
    <tradeName>+ENTIRE589010H</tradeName>
    <deviceName>Malaria</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:44.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIMAL0620DS0C</udiDi>
    <basicUdiDi>B-+ENTIMAL0620DS0C</basicUdiDi>
    <tradeName>+ENTIMAL0620DS0C</tradeName>
    <deviceName>NovaLisa® Malaria</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL0620DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:15:39.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIMAL06200E</udiDi>
    <basicUdiDi>B-+ENTIMAL06200E</basicUdiDi>
    <tradeName>+ENTIMAL06200E</tradeName>
    <deviceName>NovaLisa® Malaria</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL0620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:15:37.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-551100</udiDi>
    <basicUdiDi>B-+ENTIEIA-551100</basicUdiDi>
    <tradeName>+ENTIEIA-551100</tradeName>
    <deviceName>Malaria ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-5511</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:46.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJW20601NW-50TQL</udiDi>
    <basicUdiDi>B-YJW20601NW-50TQL</basicUdiDi>
    <tradeName>Plasmodium  Genotyping Real Time PCR Ki</tradeName>
    <deviceName>Plasmodium  Genotyping Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJW20601NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:12:28.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJW20601NW-25TQL</udiDi>
    <basicUdiDi>B-YJW20601NW-25TQL</basicUdiDi>
    <tradeName>Plasmodium  Genotyping Real Time PCR K</tradeName>
    <deviceName>Plasmodium  Genotyping Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJW20601NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:12:23.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JW20102NW-50TE5</udiDi>
    <basicUdiDi>B-JW20102NW-50TE5</basicUdiDi>
    <tradeName>Plasmodium DNA Real Time PCR Kit</tradeName>
    <deviceName>Plasmodium DNA Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JW20102NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:30.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JW20102NW-25TE5</udiDi>
    <basicUdiDi>B-JW20102NW-25TE5</basicUdiDi>
    <tradeName>Plasmodium DNA Real Time PCR Kit</tradeName>
    <deviceName>Plasmodium DNA Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JW20102NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:29.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MR172517JT</udiDi>
    <basicUdiDi>B-G2MR172517JT</basicUdiDi>
    <tradeName>RapiMal Rapid Antigen Test kit for Malaria</tradeName>
    <deviceName>RapiMal Rapid Antigen Test kit for Malaria</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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MR172517, G2MR170117</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:46:15.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR051GL</udiDi>
    <basicUdiDi>B-CNMF000054349CR051GL</basicUdiDi>
    <tradeName>Malaria Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Malaria 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>CR051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:08:12.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR057GY</udiDi>
    <basicUdiDi>B-CNMF000054349CR057GY</basicUdiDi>
    <tradeName>Malaria pf/pan Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName>Malaria pf/pan 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>CR057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:08:12.028Z</lastUpdated>
  </row>
</eudamedExport>