<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>++B379INS0251J</udiDi>
    <basicUdiDi>B-++B379INS0251J</basicUdiDi>
    <tradeName>++B379INS0251J</tradeName>
    <deviceName>Kalazar Detect™ Rapid Test</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:19.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379INS0201E</udiDi>
    <basicUdiDi>B-++B379INS0201E</basicUdiDi>
    <tradeName>++B379INS0201E</tradeName>
    <deviceName>Kalazar Detect™ Rapid Test</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:17.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379INS015VS</udiDi>
    <basicUdiDi>B-++B379INS015VS</basicUdiDi>
    <tradeName>++B379INS015VS</tradeName>
    <deviceName>Kalazar Detect™ Rapid Test</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:15.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379CP050UN</udiDi>
    <basicUdiDi>B-++B379CP050UN</basicUdiDi>
    <tradeName>++B379CP050UN</tradeName>
    <deviceName>Chagas Detect™ Plus Rapid Test</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP050</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:07.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379CL025TT</udiDi>
    <basicUdiDi>B-++B379CL025TT</basicUdiDi>
    <tradeName>++B379CL025TT</tradeName>
    <deviceName>CL Detect™ Rapid Test</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:06.269Z</lastUpdated>
  </row>
  <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>D-IFIL-402E2</udiDi>
    <basicUdiDi>B-IFIL-402E2</basicUdiDi>
    <tradeName>Filariasis IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>Filariasis IgG/IgM 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFIL-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:49.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFIL-302DV</udiDi>
    <basicUdiDi>B-IFIL-302DV</basicUdiDi>
    <tradeName>Filariasis IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>Filariasis IgG/IgM 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFIL-302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:45.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IEGC-635AD</udiDi>
    <basicUdiDi>B-IEGC-635AD</basicUdiDi>
    <tradeName>Entamoeba+Giardia+Crypto Combo Rapid Test Cassette</tradeName>
    <deviceName>Entamoeba+Giardia+Crypto Combo 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IEGC-635</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:42:57.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IEGC-6029W</udiDi>
    <basicUdiDi>B-IEGC-6029W</basicUdiDi>
    <tradeName>Entamoeba/Giardia/Crypto Rapid Test Cassette</tradeName>
    <deviceName>Entamoeba/Giardia/Crypto 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IEGC-602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:29:56.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0283JDT</udiDi>
    <basicUdiDi>B-697994388Ir0283JDT</basicUdiDi>
    <tradeName>D-697994388Ir0283JDT</tradeName>
    <deviceName>Malaria Ag Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:44.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0243ACM</udiDi>
    <basicUdiDi>B-697994388Ir0243ACM</basicUdiDi>
    <tradeName>D-697994388Ir0243ACM</tradeName>
    <deviceName>Trichomoniasis Rapid Test</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:33.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840312478</udiDi>
    <basicUdiDi>B-69743840312478</basicUdiDi>
    <tradeName>Crypto+Giardia Combo Antigen Rapid Test</tradeName>
    <deviceName>Crypto+Giardia Combo Antigen 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3027501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:00.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840310566</udiDi>
    <basicUdiDi>B-69743840310566</basicUdiDi>
    <tradeName>Babesia Antibody Rapid Test</tradeName>
    <deviceName>Babesia Antibody 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FRO111221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:22.602Z</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>
</eudamedExport>