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<eudamedExport entity="devices">
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    <udiDi>00816870020334</udiDi>
    <basicUdiDi>B-00816870020334</basicUdiDi>
    <tradeName>Folate AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Folate 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>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7525-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:09.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020327</udiDi>
    <basicUdiDi>B-00816870020327</basicUdiDi>
    <tradeName>Folate AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Folate 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>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7525-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:08.450Z</lastUpdated>
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  <row>
    <udiDi>00816870020310</udiDi>
    <basicUdiDi>B-00816870020310</basicUdiDi>
    <tradeName>Ferritin AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Ferritin 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2825-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:07.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020303</udiDi>
    <basicUdiDi>B-00816870020303</basicUdiDi>
    <tradeName>Ferritin AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Ferritin 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2825-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:06.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020297</udiDi>
    <basicUdiDi>B-00816870020297</basicUdiDi>
    <tradeName>Folate &amp; Vitamin B-12 AccuBind VAST ELISA Kit - 192 wells</tradeName>
    <deviceName>Folate &amp; Vitamin B12 (Folate/ Vit B12 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>W0102070301</emdnCode>
    <emdnDescription>VITAMIN B 12 / FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2825-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:02.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020280</udiDi>
    <basicUdiDi>B-00816870020280</basicUdiDi>
    <tradeName>Folate &amp; Vitamin B-12 AccuBind VAST ELISA Kit - 96 wells</tradeName>
    <deviceName>Folate &amp; Vitamin B12 (Folate/ Vit B12 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>W0102070301</emdnCode>
    <emdnDescription>VITAMIN B 12 / FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7825-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:01.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020259</udiDi>
    <basicUdiDi>B-00816870020259</basicUdiDi>
    <tradeName>IgE AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Immunoglobulin E (IgE) 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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2525-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:01:00.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020242</udiDi>
    <basicUdiDi>B-00816870020242</basicUdiDi>
    <tradeName>IgE AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Immunoglobulin E (IgE) 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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2525-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:00:59.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022178</udiDi>
    <basicUdiDi>081687002CA1535675S4</basicUdiDi>
    <tradeName>CA 15-3 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 15-3 (CA 15-3) 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5675-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:44:53.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020518</udiDi>
    <basicUdiDi>081687002CA1993925VC</basicUdiDi>
    <tradeName>CA 19-9 AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 19-9 (CA 19-9) 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3925-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:40:18.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020525</udiDi>
    <basicUdiDi>081687002CA1993925VC</basicUdiDi>
    <tradeName>CA 19-9 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3925-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:40:17.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022192</udiDi>
    <basicUdiDi>081687002CA1993975VT</basicUdiDi>
    <tradeName>CA 19-9 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 19-9 (CA 19-9) 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3975-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:40:17.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022208</udiDi>
    <basicUdiDi>081687002CA1993975VT</basicUdiDi>
    <tradeName>CA 19-9 AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Cancer Antigen 19-9 (CA 19-9) 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3975-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:40:17.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022239</udiDi>
    <basicUdiDi>B-00816870022239</basicUdiDi>
    <tradeName>CEA NEXT GEN  AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Carcinoembryonic Antigen Next Generation (CEA-Next Generation) 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>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4675-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:24:45.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022246</udiDi>
    <basicUdiDi>B-00816870022246</basicUdiDi>
    <tradeName>CEA NEXT GEN 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>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4675-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:24:44.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022185</udiDi>
    <basicUdiDi>B-00816870022185</basicUdiDi>
    <tradeName>CA 15-3 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>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5675-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:52:28.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020457</udiDi>
    <basicUdiDi>B-00816870020457</basicUdiDi>
    <tradeName>AFP AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) 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>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1925-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:05:02.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022260</udiDi>
    <basicUdiDi>B-00816870022260</basicUdiDi>
    <tradeName>Free β-hCG AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Free β-Subunit Human Chorionic Gonadotropin (Free ß-hCG) 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>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2075-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:47.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022253</udiDi>
    <basicUdiDi>B-00816870022253</basicUdiDi>
    <tradeName>Free β-hCG AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Free β-Subunit Human Chorionic Gonadotropin (Free ß-hCG) 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>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2075-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:46.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020662</udiDi>
    <basicUdiDi>B-00816870020662</basicUdiDi>
    <tradeName>CK-MB AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) 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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2925-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:46.148Z</lastUpdated>
  </row>
</eudamedExport>