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<eudamedExport entity="devices">
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    <udiDi>00866215000002</udiDi>
    <basicUdiDi>08662150000NOVATOMEWK</basicUdiDi>
    <tradeName>Novatome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scholten Surgical Instruments, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034588</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOCARDIAL BIOPSY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SU101-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:23.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866215000019</udiDi>
    <basicUdiDi>08662150000NOVATOMEWK</basicUdiDi>
    <tradeName>Novatome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scholten Surgical Instruments, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034588</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOCARDIAL BIOPSY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SU102-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:23.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866215000026</udiDi>
    <basicUdiDi>08662150000NOVATOMEWK</basicUdiDi>
    <tradeName>Novatome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scholten Surgical Instruments, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034588</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOCARDIAL BIOPSY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SU103-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:23.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866215000033</udiDi>
    <basicUdiDi>08662150000NOVATOMEWK</basicUdiDi>
    <tradeName>Novatome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scholten Surgical Instruments, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034588</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOCARDIAL BIOPSY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SU104-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:23.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866215000040</udiDi>
    <basicUdiDi>08662150000NOVATOMEWK</basicUdiDi>
    <tradeName>Novatome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scholten Surgical Instruments, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034588</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOCARDIAL BIOPSY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SU104-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:23.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866215000057</udiDi>
    <basicUdiDi>08662150000NOVATOMEWK</basicUdiDi>
    <tradeName>Novatome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scholten Surgical Instruments, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034588</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOCARDIAL BIOPSY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SU103-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:23.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866215000064</udiDi>
    <basicUdiDi>08662150000NOVATOMEWK</basicUdiDi>
    <tradeName>Novatome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scholten Surgical Instruments, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034588</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOCARDIAL BIOPSY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SU103-100PC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:23.389Z</lastUpdated>
  </row>
</eudamedExport>