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<eudamedExport entity="devices">
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    <udiDi>00816870020655</udiDi>
    <basicUdiDi>B-00816870020655</basicUdiDi>
    <tradeName>CK-MB AccuBind ELISA Kit - 96 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>2925-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:45.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022406</udiDi>
    <basicUdiDi>B-00816870022406</basicUdiDi>
    <tradeName>hs-CRP AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein (hs-CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3175-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:40:00.226Z</lastUpdated>
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  <row>
    <udiDi>00816870022390</udiDi>
    <basicUdiDi>B-00816870022390</basicUdiDi>
    <tradeName>hs-CRP AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein (hs-CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3175-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:39:59.413Z</lastUpdated>
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  <row>
    <udiDi>00816870022345</udiDi>
    <basicUdiDi>B-00816870022345</basicUdiDi>
    <tradeName>CK-MB AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) 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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2975-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:39:55.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020723</udiDi>
    <basicUdiDi>B-00816870020723</basicUdiDi>
    <tradeName>hs-CRP AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein (hs-CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3125-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:39:54.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020716</udiDi>
    <basicUdiDi>B-00816870020716</basicUdiDi>
    <tradeName>hs-CRP AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein (hs-CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3125-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:39:53.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022338</udiDi>
    <basicUdiDi>B-00816870022338</basicUdiDi>
    <tradeName>CK-MB AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) 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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2975-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:39:53.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870023205</udiDi>
    <basicUdiDi>081687002TG2275ZD</basicUdiDi>
    <tradeName>Tg AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Thyroglobulin (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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2275-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T11:02:52.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022291</udiDi>
    <basicUdiDi>081687002PSA21758T</basicUdiDi>
    <tradeName>PSA AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Total Prostate Specific Antigen (PSA) 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>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2175-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T11:02:51.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021768</udiDi>
    <basicUdiDi>081687002TG2225YW</basicUdiDi>
    <tradeName>Tg AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Thyroglobulin (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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2225-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T11:02:50.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020426</udiDi>
    <basicUdiDi>081687002PSAVAST842522</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuBind VAST ELISA Kit - 192 wells</tradeName>
    <deviceName>Alpha-Fetoprotein, Carcinoembryonic Antigen and Total Prostate Specific Antigen (AFP/CEA/tPSA) 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8425-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:02.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020433</udiDi>
    <basicUdiDi>081687002PSAVAST842522</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuBind VAST ELISA Kit - 480 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>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8425-300D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:02.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020440</udiDi>
    <basicUdiDi>081687002PSAVAST842522</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuBind VAST ELISA Kit - 960 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>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8425-300E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:02.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020631</udiDi>
    <basicUdiDi>081687002PSAXS8725F4</basicUdiDi>
    <tradeName>PSA-XS AccuBind ELISA Kit - 96 Well</tradeName>
    <deviceName>Total Prostate Specific Antigen Extra Sensitive (tPSA-XS) 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>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8725-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:01.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020648</udiDi>
    <basicUdiDi>081687002PSAXS8725F4</basicUdiDi>
    <tradeName>PSA-XS AccuBind ELISA Kit - 192 Well</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>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8725-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:01.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022109</udiDi>
    <basicUdiDi>081687002PSAVAST84752H</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuLite VAST CLIA Kit - 192 wells</tradeName>
    <deviceName>Alpha-Fetoprotein,Carcinoembryonic Antigen and Total Prostate Specific Antigen (AFP/CEA/tPSA) 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030122</emdnCode>
    <emdnDescription>EARLY PROSTATE CANCER ANTIGEN - 2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8475-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:01.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022116</udiDi>
    <basicUdiDi>081687002PSAVAST84752H</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuLite VAST CLIA Kit - 480 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>W0102030122</emdnCode>
    <emdnDescription>EARLY PROSTATE CANCER ANTIGEN - 2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8475-300D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:01.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022123</udiDi>
    <basicUdiDi>081687002PSAVAST84752H</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuLite VAST CLIA Kit - 960 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>W0102030122</emdnCode>
    <emdnDescription>EARLY PROSTATE CANCER ANTIGEN - 2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8475-300E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:01.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022314</udiDi>
    <basicUdiDi>081687002PSAXS8775FK</basicUdiDi>
    <tradeName>PSA-XS AccuLite CLIA Kit - 96 Wells</tradeName>
    <deviceName>Total Prostate Specific Antigen Extra Sensitive (tPSA-XS) 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>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8775-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:00.890Z</lastUpdated>
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    <udiDi>00816870022321</udiDi>
    <basicUdiDi>081687002PSAXS8775FK</basicUdiDi>
    <tradeName>PSA-XS 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8775-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-08T10:58:00.723Z</lastUpdated>
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</eudamedExport>