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<eudamedExport entity="devices">
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    <basicUdiDi>081687002PSAXS8725F4</basicUdiDi>
    <tradeName>PSA-XS AccuBind ELISA Kit - 96 Well</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8725-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.312Z</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>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8725-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022109</udiDi>
    <basicUdiDi>081687002PSAVAST84752H</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuLite VAST CLIA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EARLY PROSTATE CANCER ANTIGEN - 2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8475-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.277Z</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>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EARLY PROSTATE CANCER ANTIGEN - 2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8475-300D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.266Z</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>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8475-300E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022154</udiDi>
    <basicUdiDi>081687002CA1253075Q7</basicUdiDi>
    <tradeName>CA-125 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3075-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022161</udiDi>
    <basicUdiDi>081687002CA1253075Q7</basicUdiDi>
    <tradeName>CA-125 AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3075-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022178</udiDi>
    <basicUdiDi>081687002CA1535675S4</basicUdiDi>
    <tradeName>CA 15-3 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5675-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022185</udiDi>
    <basicUdiDi>081687002CA1535675S4</basicUdiDi>
    <tradeName>CA 15-3 AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5675-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022192</udiDi>
    <basicUdiDi>081687002CA1993975VT</basicUdiDi>
    <tradeName>CA 19-9 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3975-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022208</udiDi>
    <basicUdiDi>081687002CA1993975VT</basicUdiDi>
    <tradeName>CA 19-9 AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3975-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022239</udiDi>
    <basicUdiDi>081687002CEANG4675LL</basicUdiDi>
    <tradeName>CEA NEXT GEN  AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4675-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022246</udiDi>
    <basicUdiDi>081687002CEANG4675LL</basicUdiDi>
    <tradeName>CEA NEXT GEN AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4675-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022277</udiDi>
    <basicUdiDi>081687002FPSA2375J8</basicUdiDi>
    <tradeName>Free PSA AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2375-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022284</udiDi>
    <basicUdiDi>081687002FPSA2375J8</basicUdiDi>
    <tradeName>Free PSA AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2375-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022314</udiDi>
    <basicUdiDi>081687002PSAXS8775FK</basicUdiDi>
    <tradeName>PSA-XS AccuLite CLIA Kit - 96 Wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8775-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.087Z</lastUpdated>
  </row>
  <row>
    <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>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8775-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024448</udiDi>
    <basicUdiDi>081687002IN006-3UR</basicUdiDi>
    <tradeName>00816870024448</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN006-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.049Z</lastUpdated>
  </row>
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