<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-CHIK-D02a2U</udiDi>
    <basicUdiDi>B-CHIK-D02a2U</basicUdiDi>
    <tradeName>Chikungunya IgG/lgM Antibody Rapid Test</tradeName>
    <deviceName>Chikungunya IgG/lgM Antibody 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHIK-D02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:05:42.065Z</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>86979834610313</udiDi>
    <basicUdiDi>B-86979834610313</basicUdiDi>
    <tradeName>Malaria Test Device(whole blood)</tradeName>
    <deviceName>Malaria Test Device(whole blood)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL0238</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:30.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>86979834610122</udiDi>
    <basicUdiDi>B-86979834610122</basicUdiDi>
    <tradeName>Malaria pf/pv Test Kit(Whole blood)</tradeName>
    <deviceName>Malaria pf/pv Test Kit(Whole blood)MAL0041</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL0041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:08.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>86979834610047</udiDi>
    <basicUdiDi>B-86979834610047</basicUdiDi>
    <tradeName>Schistosoma Antibody Test Kit(Serum/plasma/whole blood)</tradeName>
    <deviceName>SEA0035</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEA0035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:02.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942153153</udiDi>
    <basicUdiDi>B-84365942153153</basicUdiDi>
    <tradeName>biotical Crypto Card (+PC +NC)</tradeName>
    <deviceName>biotical Crypto Card (+PC +NC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25KCN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:13:03.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942153088</udiDi>
    <basicUdiDi>B-84365942153088</basicUdiDi>
    <tradeName>biotical Crypto Card (+PC)</tradeName>
    <deviceName>biotical Crypto Card (+PC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25KC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:13:02.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942152920</udiDi>
    <basicUdiDi>B-84365942152920</basicUdiDi>
    <tradeName>biotical Crypto Card</tradeName>
    <deviceName>biotical Crypto Card</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25K</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:13:01.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942152616</udiDi>
    <basicUdiDi>B-84365942152616</basicUdiDi>
    <tradeName>biotical Giardia Card (+PC +NC)</tradeName>
    <deviceName>biotical Giardia Card (+PC +NC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25GCN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:56.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942152548</udiDi>
    <basicUdiDi>B-84365942152548</basicUdiDi>
    <tradeName>biotical Giardia Card (+PC)</tradeName>
    <deviceName>biotical Giardia Card (+PC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25GC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:55.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942152470</udiDi>
    <basicUdiDi>B-84365942152470</basicUdiDi>
    <tradeName>biotical Giardia Card</tradeName>
    <deviceName>biotical Giardia Card</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:49.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779143XYK2</udiDi>
    <basicUdiDi>B-84295779143XYK2</basicUdiDi>
    <tradeName>SIMPLE ENTAMOEBA / STICK ENTAMOEBA</tradeName>
    <deviceName>SIMPLE ENTAMOEBA / STICK ENTAMOEBA</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.143.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:12.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779023XMHH</udiDi>
    <basicUdiDi>B-84295779023XMHH</basicUdiDi>
    <tradeName>SIMPLE CRYPTO-GIARDIA / STICK CRYPTO-GIARDIA</tradeName>
    <deviceName>SIMPLE CRYPTO-GIARDIA / STICK CRYPTO-GIARDIA</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.023.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:39.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779022XKH8</udiDi>
    <basicUdiDi>B-84295779022XKH8</basicUdiDi>
    <tradeName>SIMPLE CRYPTO / STICK CRYPTO</tradeName>
    <deviceName>SIMPLE CRYPTO / STICK CRYPTO</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.022.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:38.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779019XWJU</udiDi>
    <basicUdiDi>B-84295779019XWJU</basicUdiDi>
    <tradeName>SIMPLE GIARDIA / STICK GIARDIA</tradeName>
    <deviceName>SIMPLE GIARDIA / STICK GIARDIA</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.019.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:38.861Z</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>16972698603737</udiDi>
    <basicUdiDi>B-16972698603737</basicUdiDi>
    <tradeName>Cryptosporidium Antigen Rapid Test</tradeName>
    <deviceName>Cryptosporidium Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:58.920Z</lastUpdated>
  </row>
</eudamedExport>