<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00816870021461</udiDi>
    <basicUdiDi>B-00816870021461</basicUdiDi>
    <tradeName>17-OHP SI - AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9925-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:21:30.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022895</udiDi>
    <basicUdiDi>B-00816870022895</basicUdiDi>
    <tradeName>17α-OHP SI AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9975-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:21:30.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022901</udiDi>
    <basicUdiDi>B-00816870022901</basicUdiDi>
    <tradeName>17α-OHP SI AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9975-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:21:29.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024783</udiDi>
    <basicUdiDi>B-00816870024783</basicUdiDi>
    <tradeName>Anti-TPO AccuBind ELISA Kits - 192 wells</tradeName>
    <deviceName>Thyroid Peroxidase Ab (Anti-TPO) 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>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1125-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:52.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024790</udiDi>
    <basicUdiDi>B-00816870024790</basicUdiDi>
    <tradeName>Anti-TPO AccuLite CLIA Kits - 192 wells</tradeName>
    <deviceName>Thyroid Peroxidase Ab (Anti-TPO) AccuLite® CLIA 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>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1175-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:50.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024523</udiDi>
    <basicUdiDi>B-00816870024523</basicUdiDi>
    <tradeName>PTH Intact AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Parathyroid Hormone - Intact (PTH 2nd Gen) AccuLite® CLIA 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>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9075-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:33.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024516</udiDi>
    <basicUdiDi>B-00816870024516</basicUdiDi>
    <tradeName>PTH Intact AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Parathyroid Hormone - Intact (PTH 2nd Gen) 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>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9025-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:32.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024509</udiDi>
    <basicUdiDi>B-00816870024509</basicUdiDi>
    <tradeName>Anti-Tg AccuLite CLIA Kits - 192 wells</tradeName>
    <deviceName>Thyroglobulin Ab (Anti-Tg) AccuLite® CLIA 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>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1075-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:31.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024493</udiDi>
    <basicUdiDi>B-00816870024493</basicUdiDi>
    <tradeName>Anti-Tg AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Thyroglobulin Ab (Anti-Tg) 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>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1025-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:30.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024486</udiDi>
    <basicUdiDi>B-00816870024486</basicUdiDi>
    <tradeName>Anti-CCP IgG AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Anti-Cyclic Citrullinated Peptide IgG (Anti-CCP) AccuLite® CLIA 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12775-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:26.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024479</udiDi>
    <basicUdiDi>B-00816870024479</basicUdiDi>
    <tradeName>Anti-CCP IgG AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Anti-Cyclic Citrullinated Peptide IgG (Anti-CCP) AccuLite® CLIA 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12775-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:25.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024462</udiDi>
    <basicUdiDi>B-00816870024462</basicUdiDi>
    <tradeName>Anti-CCP IgG AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Anti-Cyclic Citrullinated Peptide IgG (Anti-CCP) 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12725-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:24.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024455</udiDi>
    <basicUdiDi>B-00816870024455</basicUdiDi>
    <tradeName>Anti-CCP IgG AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Anti-Cyclic Citrullinated Peptide IgG (Anti-CCP) 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12725-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:23.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023762</udiDi>
    <basicUdiDi>B-00816870023762</basicUdiDi>
    <tradeName>PTH Whole &amp; Intact AccuBind VAST ELISA Kit - 96 wells</tradeName>
    <deviceName>Parathyroid Hormone (PTH) Whole &amp; Intact AccuBind® VAST 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>W0102060313</emdnCode>
    <emdnDescription>PARATHYROID HORMONE (C-/N-TERMINAL, M-REGIONAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10025-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:19.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023748</udiDi>
    <basicUdiDi>B-00816870023748</basicUdiDi>
    <tradeName>PTH Whole &amp; Intact AccuLite VAST CLIA Kit - 96 wells</tradeName>
    <deviceName>Parathyroid Hormone (PTH) Whole &amp; Intact AccuLite® VAST CLIA 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>W0102060313</emdnCode>
    <emdnDescription>PARATHYROID HORMONE (C-/N-TERMINAL, M-REGIONAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10075-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:18.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023731</udiDi>
    <basicUdiDi>B-00816870023731</basicUdiDi>
    <tradeName>PTH Whole &amp; Intact AccuLite VAST CLIA Kit - 192 wells</tradeName>
    <deviceName>Parathyroid Hormone (PTH) Whole &amp; Intact AccuLite® VAST CLIA 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>W0102060313</emdnCode>
    <emdnDescription>PARATHYROID HORMONE (C-/N-TERMINAL, M-REGIONAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10075-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:17.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023724</udiDi>
    <basicUdiDi>B-00816870023724</basicUdiDi>
    <tradeName>Calcitonin AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Calcitonin 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9325-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:17.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023717</udiDi>
    <basicUdiDi>B-00816870023717</basicUdiDi>
    <tradeName>Calcitonin AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Calcitonin 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9325-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:12.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023700</udiDi>
    <basicUdiDi>B-00816870023700</basicUdiDi>
    <tradeName>Calcitonin AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Calcitonin AccuLite® CLIA 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9375-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:11.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023694</udiDi>
    <basicUdiDi>B-00816870023694</basicUdiDi>
    <tradeName>Calcitonin AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Calcitonin AccuLite® CLIA 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9375-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:10.505Z</lastUpdated>
  </row>
</eudamedExport>