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<eudamedExport entity="devices">
  <row>
    <udiDi>06936983104715</udiDi>
    <basicUdiDi>6970277510000HXR</basicUdiDi>
    <tradeName>Malaria P.f. /P.v. Rapid Test</tradeName>
    <deviceName>Malaria P.f. /P.v. Rapid Test</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPV-N402-20</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:56:59.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983104685</udiDi>
    <basicUdiDi>6970277510000GXP</basicUdiDi>
    <tradeName>Malaria P.f. /Pan Rapid Test</tradeName>
    <deviceName>Malaria P.f. /Pan Rapid Test</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPN-N402-20</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:56:57.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840304558</udiDi>
    <basicUdiDi>B-69743840304558</basicUdiDi>
    <tradeName>Malaria pf/pan One Step Rapid Test</tradeName>
    <deviceName>Malaria pf/pan One Step Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</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>Artık piyasada değil</deviceStatus>
    <reference>3020603</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:05.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840304480</udiDi>
    <basicUdiDi>B-69743840304480</basicUdiDi>
    <tradeName>Malaria pf/pv One Step Rapid Test</tradeName>
    <deviceName>Malaria pf/pv One Step Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</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>Artık piyasada değil</deviceStatus>
    <reference>3020602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:02.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL005GVVC</udiDi>
    <basicUdiDi>B-697424646MAL005GVVC</basicUdiDi>
    <tradeName>Malaria P.v./Pan Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria P.v./Pan Rapid Test (Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4022c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:14.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL004GTV3</udiDi>
    <basicUdiDi>B-697424646MAL004GTV3</basicUdiDi>
    <tradeName>Malaria P.f./Pan Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria P.f./Pan Rapid Test (Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4022b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:12.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL003GRUS</udiDi>
    <basicUdiDi>B-697424646MAL003GRUS</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test (Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4022a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:10.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL003GKUC</udiDi>
    <basicUdiDi>B-697424646MAL003GKUC</basicUdiDi>
    <tradeName>Malaria P.f./Pan Rapid Test  Kit(Whole Blood)</tradeName>
    <deviceName>Malaria P.f./Pan Rapid Test  Kit(Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4022b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:09.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL002GPUH</udiDi>
    <basicUdiDi>B-697424646MAL002GPUH</basicUdiDi>
    <tradeName>Malaria Pan Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria Pan Rapid Test (Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4011c/MAL-4012c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:07.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL002GKU7</udiDi>
    <basicUdiDi>B-697424646MAL002GKU7</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Rapid Test  Kit(Whole Blood)</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test  Kit(Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4022a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:05.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL001GMU6</udiDi>
    <basicUdiDi>B-697424646MAL001GMU6</basicUdiDi>
    <tradeName>Malaria  P.v. Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria  P.v. Rapid Test (Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4011b/MAL-4012b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:03.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL001GKU2</udiDi>
    <basicUdiDi>B-697424646MAL001GKU2</basicUdiDi>
    <tradeName>Malaria P.f. Rapid Test  Kit(Whole Blood)</tradeName>
    <deviceName>Malaria P.f. Rapid Test  Kit(Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4011/MAL-4012a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:01.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL000GKTV</udiDi>
    <basicUdiDi>B-697424646MAL000GKTV</basicUdiDi>
    <tradeName>Malaria  P.f. Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria  P.f. Rapid Test (Whole Blood)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4011a/MAL-4012a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:59.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712009038Z</udiDi>
    <basicUdiDi>B-69717712009038Z</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Malaria Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-W21- FV（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:08.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>6970277510023AXW</udiDi>
    <basicUdiDi>B-6970277510023AXW</basicUdiDi>
    <tradeName>6970277510023AXW</tradeName>
    <deviceName>Malaria P.f./P.v. 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>IMPV-401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:32.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991703QP</udiDi>
    <basicUdiDi>B-693757991703QP</basicUdiDi>
    <tradeName>Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</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>Artık piyasada değil</deviceStatus>
    <reference>MA-Pan/Pf 50170301 MA-Pan/Pf 25170302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:16.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991702QM</udiDi>
    <basicUdiDi>B-693757991702QM</basicUdiDi>
    <tradeName>Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</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>Artık piyasada değil</deviceStatus>
    <reference>MA-Pf 50170101 MA-Pf 25170102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:14.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991701QK</udiDi>
    <basicUdiDi>B-693757991701QK</basicUdiDi>
    <tradeName>Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</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>Artık piyasada değil</deviceStatus>
    <reference>MA-Pf/Pv 50170201 MA-Pf/Pv 25170202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:12.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182723590</udiDi>
    <basicUdiDi>B-62230182723590</basicUdiDi>
    <tradeName>Malaria Antigen Test (Whole Blood) For Plasmodium falciparum &amp; vivax</tradeName>
    <deviceName>Malaria Antigen Test (Whole Blood) For Plasmodium falciparum &amp; vivax</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</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>D-796 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:31.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-472040N-10YH</udiDi>
    <basicUdiDi>B-nvm-472040N-10YH</basicUdiDi>
    <tradeName>NADAL® Malaria Pf/Pan Ag 4 Species plus Test</tradeName>
    <deviceName>Malaria Pf/Pan Ag 4 Species plus 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>472040N-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:24.912Z</lastUpdated>
  </row>
</eudamedExport>