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<eudamedExport entity="devices">
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    <udiDi>00816870023410</udiDi>
    <basicUdiDi>B-00816870023410</basicUdiDi>
    <tradeName>Vit D Direct AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>25-OH Vitamin D Total (Vit D Direct) 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9425-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:09.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023403</udiDi>
    <basicUdiDi>B-00816870023403</basicUdiDi>
    <tradeName>Vit D Direct AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>25-OH Vitamin D Total (Vit D Direct) 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9425-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:04.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023373</udiDi>
    <basicUdiDi>B-00816870023373</basicUdiDi>
    <tradeName>Vit D Direct AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>25-OH Vitamin D Total (Vit D Direct) 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9475-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:04.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023366</udiDi>
    <basicUdiDi>B-00816870023366</basicUdiDi>
    <tradeName>Vit D Direct AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>25-OH Vitamin D Total (Vit D Direct) 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9475-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:03.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022086</udiDi>
    <basicUdiDi>B-00816870022086</basicUdiDi>
    <tradeName>PTH Intact AccuLite CLIA Kit - 96 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>9075-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:04:02.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022079</udiDi>
    <basicUdiDi>B-00816870022079</basicUdiDi>
    <tradeName>Anti-TPO AccuLite CLIA Kits - 96 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>1175-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:57.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022062</udiDi>
    <basicUdiDi>B-00816870022062</basicUdiDi>
    <tradeName>Anti-Tg AccuLite CLIA Kits - 96 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>1075-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:56.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022055</udiDi>
    <basicUdiDi>B-00816870022055</basicUdiDi>
    <tradeName>Vitamin B-12 AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Vitamin B12 (Vit B12) 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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7675-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:56.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022048</udiDi>
    <basicUdiDi>B-00816870022048</basicUdiDi>
    <tradeName>Vitamin B-12 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Vitamin B12 (Vit B12) 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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7675-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:55.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022031</udiDi>
    <basicUdiDi>B-00816870022031</basicUdiDi>
    <tradeName>sTfR AccuBind CLIA Kit - 192 wells</tradeName>
    <deviceName>Soluble Transferrin Receptor (sTfR) 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>W0102070104</emdnCode>
    <emdnDescription>SOLUBLE TRANSFERRIN RECEPTOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8675-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:50.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022024</udiDi>
    <basicUdiDi>B-00816870022024</basicUdiDi>
    <tradeName>sTfR AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Soluble Transferrin Receptor (sTfR) 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>W0102070104</emdnCode>
    <emdnDescription>SOLUBLE TRANSFERRIN RECEPTOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8675-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:49.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022017</udiDi>
    <basicUdiDi>B-00816870022017</basicUdiDi>
    <tradeName>Folate AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Folate 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>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7575-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:48.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022000</udiDi>
    <basicUdiDi>B-00816870022000</basicUdiDi>
    <tradeName>Folate AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Folate 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>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7575-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:48.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021997</udiDi>
    <basicUdiDi>B-00816870021997</basicUdiDi>
    <tradeName>Ferritin AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Ferritin 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2875-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:44.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021980</udiDi>
    <basicUdiDi>B-00816870021980</basicUdiDi>
    <tradeName>Ferritin AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Ferritin 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2875-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:42.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021973</udiDi>
    <basicUdiDi>B-00816870021973</basicUdiDi>
    <tradeName>Folate &amp; Vitamin B-12 AccuLite VAST CLIA Kit - 192 wells</tradeName>
    <deviceName>Folate &amp; Vitamin B12 (Folate/ Vit B12 VAST) 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>W0102070301</emdnCode>
    <emdnDescription>VITAMIN B 12 / FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7875-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:03:41.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021966</udiDi>
    <basicUdiDi>B-00816870021966</basicUdiDi>
    <tradeName>Folate &amp; Vitamin B-12 AccuLite VAST 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>W0102070301</emdnCode>
    <emdnDescription>VITAMIN B 12 / FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7875-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:30.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021935</udiDi>
    <basicUdiDi>B-00816870021935</basicUdiDi>
    <tradeName>IgE 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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2575-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:30.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021928</udiDi>
    <basicUdiDi>B-00816870021928</basicUdiDi>
    <tradeName>IgE AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Immunoglobulin E (IgE) 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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2575-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:29.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020587</udiDi>
    <basicUdiDi>B-00816870020587</basicUdiDi>
    <tradeName>Free β-hCG AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Free β-Subunit Human Chorionic Gonadotropin (Free ß-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>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2025-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:28.449Z</lastUpdated>
  </row>
</eudamedExport>