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<eudamedExport entity="devices">
  <row>
    <udiDi>00816870021362</udiDi>
    <basicUdiDi>B-00816870021362</basicUdiDi>
    <tradeName>DHEA AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Dehydroepiandrosterone (DHEA) 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>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7425-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:00:17.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021355</udiDi>
    <basicUdiDi>B-00816870021355</basicUdiDi>
    <tradeName>DHEA AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Dehydroepiandrosterone (DHEA) 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>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7425-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:00:10.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021348</udiDi>
    <basicUdiDi>B-00816870021348</basicUdiDi>
    <tradeName>DHEA-S AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Dehydroepiandrosterone Sulfate (DHEA-S) 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>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5125-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:59:55.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021331</udiDi>
    <basicUdiDi>B-00816870021331</basicUdiDi>
    <tradeName>DHEA-S AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Dehydroepiandrosterone Sulfate (DHEA-S) 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>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5125-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:59:52.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021324</udiDi>
    <basicUdiDi>B-00816870021324</basicUdiDi>
    <tradeName>Cortisol AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Cortisol 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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3625-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:59:49.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021317</udiDi>
    <basicUdiDi>B-00816870021317</basicUdiDi>
    <tradeName>Cortisol AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Cortisol 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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3625-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:59:45.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021270</udiDi>
    <basicUdiDi>B-00816870021270</basicUdiDi>
    <tradeName>N-TBG AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Neonatal Thyroxine Binding Globulin (N-TBG) 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8925-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:59:27.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021263</udiDi>
    <basicUdiDi>B-00816870021263</basicUdiDi>
    <tradeName>N-TBG AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Neonatal Thyroxine Binding Globulin (N-TBG) 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8925-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:59:24.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021225</udiDi>
    <basicUdiDi>B-00816870021225</basicUdiDi>
    <tradeName>N-T4 AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Neonatal Thyroxine (N-T4) 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>W01020411</emdnCode>
    <emdnDescription>NEONATAL THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2625-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:59:20.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021218</udiDi>
    <basicUdiDi>B-00816870021218</basicUdiDi>
    <tradeName>N-T4 AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Neonatal Thyroxine (N-T4) 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>W01020411</emdnCode>
    <emdnDescription>NEONATAL THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2625-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:59:17.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021171</udiDi>
    <basicUdiDi>B-00816870021171</basicUdiDi>
    <tradeName>N-17-OHP AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Neonatal 17α-OH Progesterone (N-17-OHP) 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>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5525-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:58:58.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021164</udiDi>
    <basicUdiDi>B-00816870021164</basicUdiDi>
    <tradeName>N-17-OHP AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Neonatal 17α-OH Progesterone (N-17-OHP) 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>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5525-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:58:54.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021140</udiDi>
    <basicUdiDi>B-00816870021140</basicUdiDi>
    <tradeName>N-TSH AccuBind ELISA Kit - 960 wells</tradeName>
    <deviceName>Neonatal Thyrotropin (N-TSH) 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>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3425-300E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:58:51.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021133</udiDi>
    <basicUdiDi>B-00816870021133</basicUdiDi>
    <tradeName>N-TSH AccuBind ELISA Kit - 480 wells</tradeName>
    <deviceName>Neonatal Thyrotropin (N-TSH) 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>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3425-300D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:58:48.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021126</udiDi>
    <basicUdiDi>B-00816870021126</basicUdiDi>
    <tradeName>N-TSH AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Neonatal Thyrotropin (N-TSH) 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>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3425-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:56:47.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021119</udiDi>
    <basicUdiDi>B-00816870021119</basicUdiDi>
    <tradeName>N-TSH AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Neonatal Thyrotropin (N-TSH) 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>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3425-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:56:40.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021102</udiDi>
    <basicUdiDi>B-00816870021102</basicUdiDi>
    <tradeName>Anti-H. Pylori IgG AccuBind® ELISA Test System</tradeName>
    <deviceName>Anti-H. Pylori IgG 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>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1425-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:56:36.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021096</udiDi>
    <basicUdiDi>B-00816870021096</basicUdiDi>
    <tradeName>Anti-H. Pylori IgM AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Anti-H. Pylori IgM 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>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1525-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:56:33.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021089</udiDi>
    <basicUdiDi>B-00816870021089</basicUdiDi>
    <tradeName>Anti-H. Pylori IgA AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Anti-H. Pylori IgA 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>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1625-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:56:16.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021072</udiDi>
    <basicUdiDi>B-00816870021072</basicUdiDi>
    <tradeName>hGH AccuBind ELISA Kit - 192 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>1725-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T13:56:12.910Z</lastUpdated>
  </row>
</eudamedExport>