<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>++M52108131CB3</udiDi>
    <basicUdiDi>B-++M52108131CB3</basicUdiDi>
    <tradeName>EIAgen Detect HIV Combo Kit</tradeName>
    <deviceName>EIAgen Detect HIV Combo Kit</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030404</emdnCode>
    <emdnDescription>HIV MULTIPLE AG/AB COMBI TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081311C / 081312C / 081315C</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:18.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M52107106LG</udiDi>
    <basicUdiDi>B-++M52107106LG</basicUdiDi>
    <tradeName>EIAgen HCV Ab (v.4) Kit</tradeName>
    <deviceName>EIAgen HCV Ab (v.4)</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>071067 / 071064 / 071068</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:18.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379ZKM217Q</udiDi>
    <basicUdiDi>B-++B379ZKM217Q</basicUdiDi>
    <tradeName>++B379ZKM217Q</tradeName>
    <deviceName>ZIKV Detect™ 2.0 IgM Capture ELISA</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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKM2-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:27.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379WNMS1AC</udiDi>
    <basicUdiDi>B-++B379WNMS1AC</basicUdiDi>
    <tradeName>++B379WNMS1AC</tradeName>
    <deviceName>West Nile Detect™ IgM Capture ELISA</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>W0105040626</emdnCode>
    <emdnDescription>WEST NILE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WNMS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:25.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379STMS1AA</udiDi>
    <basicUdiDi>B-++B379STMS1AA</basicUdiDi>
    <tradeName>++B379STMS1AA</tradeName>
    <deviceName>Scrub Typhus Detect™ IgM ELISA</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>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STMS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:23.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379STGS19C</udiDi>
    <basicUdiDi>B-++B379STGS19C</basicUdiDi>
    <tradeName>++B379STGS19C</tradeName>
    <deviceName>Scrub Typhus Detect™ IgG ELISA</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>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STGS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:21.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379JEMS13W</udiDi>
    <basicUdiDi>B-++B379JEMS13W</basicUdiDi>
    <tradeName>++B379JEMS13W</tradeName>
    <deviceName>JE Detect™ IgM Antibody Capture ELISA (MAC-ELISA)</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>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JEMS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:19.877Z</lastUpdated>
  </row>
  <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>++B379DNS1RDSXB</udiDi>
    <basicUdiDi>B-++B379DNS1RDSXB</basicUdiDi>
    <tradeName>++B379DNS1RDSXB</tradeName>
    <deviceName>Dengue NS1 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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNS1-RD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:13.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379DNS11ZK</udiDi>
    <basicUdiDi>B-++B379DNS11ZK</basicUdiDi>
    <tradeName>++B379DNS11ZK</tradeName>
    <deviceName>DENV Detect™ NS1 ELISA</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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNS1-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:12.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379DDMS1ZJ</udiDi>
    <basicUdiDi>B-++B379DDMS1ZJ</basicUdiDi>
    <tradeName>++B379DDMS1ZJ</tradeName>
    <deviceName>DENV Detect™ IgM Capture ELISA</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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDMS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:11.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379DDGS1YL</udiDi>
    <basicUdiDi>B-++B379DDGS1YL</basicUdiDi>
    <tradeName>++B379DDGS1YL</tradeName>
    <deviceName>DENV Detect™ IgG ELISA</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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDGS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:08.658Z</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>++B379CHKMC2C</udiDi>
    <basicUdiDi>B-++B379CHKMC2C</basicUdiDi>
    <tradeName>++B379CHKMC2C</tradeName>
    <deviceName>CHIKjj Detect™ IgM ELISA</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>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHKM-C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:04.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B379CHKGCZP</udiDi>
    <basicUdiDi>B-++B379CHKGCZP</basicUdiDi>
    <tradeName>++B379CHKGCZP</tradeName>
    <deviceName>CHIKjj Detect™ IgG ELISA</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>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHKG-C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:02.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANVD510KZ</udiDi>
    <basicUdiDi>B-++B261CANVD510KZ</basicUdiDi>
    <tradeName>++B261CANVD510KZ</tradeName>
    <deviceName>25-Hydroxyvitamin D ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-VD-510</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:00.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANTSH408068</udiDi>
    <basicUdiDi>B-++B261CANTSH408068</basicUdiDi>
    <tradeName>++B261CANTSH408068</tradeName>
    <deviceName>Thyroid Stimulating Hormone (TSH) ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-TSH-4080</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:59.851Z</lastUpdated>
  </row>
</eudamedExport>