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<eudamedExport entity="devices">
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    <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>D-697424646LEI002GZVF</udiDi>
    <basicUdiDi>B-697424646LEI002GZVF</basicUdiDi>
    <tradeName>Leishmaniasis IgG/IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Leishmaniasis IgG/IgM Rapid Test (Serum/Plasma)</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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEI-3021/LEI-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:50.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646LEI001GXV6</udiDi>
    <basicUdiDi>B-697424646LEI001GXV6</basicUdiDi>
    <tradeName>Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEI-4021/LEI-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:33.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646LEI000GVUV</udiDi>
    <basicUdiDi>B-697424646LEI000GVUV</basicUdiDi>
    <tradeName>Leishmaniasis Rapid Test (Whole Blood/serum/plasma)</tradeName>
    <deviceName>Leishmaniasis Rapid Test (Whole Blood/serum/plasma)</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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEI-4011/LEI-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:32.692Z</lastUpdated>
  </row>
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    <udiDi>D-697424646CHA002CMM9</udiDi>
    <basicUdiDi>B-697424646CHA002CMM9</basicUdiDi>
    <tradeName>Chagas Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Chagas Rapid Test (Serum/Plasma)</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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-3011/CHA-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:38.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CHA001CKLY</udiDi>
    <basicUdiDi>B-697424646CHA001CKLY</basicUdiDi>
    <tradeName>Chagas Rapid Test (WB/S/P)</tradeName>
    <deviceName>Chagas Rapid Test (WB/S/P)</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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-4011/CHA-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:38.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CHA000CHLM</udiDi>
    <basicUdiDi>B-697424646CHA000CHLM</basicUdiDi>
    <tradeName>Chagas Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Chagas Rapid Test (Whole Blood/Serum/Plasma)</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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-4011/CHA-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:37.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440212584</udiDi>
    <basicUdiDi>84354402IDXGASTROB_NE77</basicUdiDi>
    <tradeName>CerTest Crypto+Giardia+Entamoeba</tradeName>
    <deviceName>CerTest Crypto+Giardia+Entamoeba</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE872001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:46.238Z</lastUpdated>
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</eudamedExport>