<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00816870021065</udiDi>
    <basicUdiDi>B-00816870021065</basicUdiDi>
    <tradeName>hGH AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Human Growth Hormone (hGH) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1725-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:56:09.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021058</udiDi>
    <basicUdiDi>B-00816870021058</basicUdiDi>
    <tradeName>PRLs AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Prolactin Hormone Sequential (PRLs) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4425-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:56:02.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021041</udiDi>
    <basicUdiDi>B-00816870021041</basicUdiDi>
    <tradeName>PRLs AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Prolactin Hormone Sequential (PRLs) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4425-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:55:45.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021034</udiDi>
    <basicUdiDi>B-00816870021034</basicUdiDi>
    <tradeName>PRL AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Prolactin Hormone (PRL) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>725-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:55:42.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021027</udiDi>
    <basicUdiDi>B-00816870021027</basicUdiDi>
    <tradeName>PRL AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Prolactin Hormone (PRL) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>725-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:55:38.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020990</udiDi>
    <basicUdiDi>B-00816870020990</basicUdiDi>
    <tradeName>LH AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Luteinizing Hormone (LH) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:55:34.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020983</udiDi>
    <basicUdiDi>B-00816870020983</basicUdiDi>
    <tradeName>LH AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Luteinizing Hormone (LH) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:55:13.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020976</udiDi>
    <basicUdiDi>B-00816870020976</basicUdiDi>
    <tradeName>Rapid hCG AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Rapid β-Human Chorionic Gonadotropin (hCG-Rapid) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3325-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:55:09.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020969</udiDi>
    <basicUdiDi>B-00816870020969</basicUdiDi>
    <tradeName>Rapid hCG AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Rapid β-Human Chorionic Gonadotropin (hCG-Rapid) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3325-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:55:06.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020952</udiDi>
    <basicUdiDi>B-00816870020952</basicUdiDi>
    <tradeName>hCG-XR AccuBind ELISA - 192 Wells</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin Extended Range (hCG-XR) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8825-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:55:02.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020945</udiDi>
    <basicUdiDi>B-00816870020945</basicUdiDi>
    <tradeName>hCG-XR AccuBind ELISA - 96 Wells</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin Extended Range (hCG-XR) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8825-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:54:29.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020938</udiDi>
    <basicUdiDi>B-00816870020938</basicUdiDi>
    <tradeName>hCG AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (hCG) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>825-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:54:26.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020921</udiDi>
    <basicUdiDi>B-00816870020921</basicUdiDi>
    <tradeName>hCG AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (hCG) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>825-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:54:22.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020914</udiDi>
    <basicUdiDi>B-00816870020914</basicUdiDi>
    <tradeName>FSH AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>425-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:54:18.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020907</udiDi>
    <basicUdiDi>B-00816870020907</basicUdiDi>
    <tradeName>FSH AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>425-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:53:59.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020884</udiDi>
    <basicUdiDi>B-00816870020884</basicUdiDi>
    <tradeName>AFP, hCG &amp; uE3 AccuBind VAST ELISA Kit - 192 wells</tradeName>
    <deviceName>Alfa-Feto Protein/ β-Human Chorionic Gonadotropin/ Unconjugated Estriol (AFP/ hCG/ uE3 VAST) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050202</emdnCode>
    <emdnDescription>ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8525-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:53:56.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020846</udiDi>
    <basicUdiDi>B-00816870020846</basicUdiDi>
    <tradeName>Rapid Insulin AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Rapid Insulin AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5825-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:53:52.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020839</udiDi>
    <basicUdiDi>B-00816870020839</basicUdiDi>
    <tradeName>Rapid Insulin AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Rapid Insulin AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5825-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:53:48.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020822</udiDi>
    <basicUdiDi>B-00816870020822</basicUdiDi>
    <tradeName>Insulin AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Insulin AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2425-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:53:29.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020815</udiDi>
    <basicUdiDi>B-00816870020815</basicUdiDi>
    <tradeName>Insulin AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Insulin AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2425-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:53:25.698Z</lastUpdated>
  </row>
</eudamedExport>