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    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129910</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:44.015Z</lastUpdated>
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    <udiDi>00851869007033</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129918</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.999Z</lastUpdated>
  </row>
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    <udiDi>00851869007040</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129929</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.983Z</lastUpdated>
  </row>
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    <udiDi>00851869007057</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129930</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007088</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>CirCLIQ®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129956</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.950Z</lastUpdated>
  </row>
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    <udiDi>00851869007156</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>CirCLIQ®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129969</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007187</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129971</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007279</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129980</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007286</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129981</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007293</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129982</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007309</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129983</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007316</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129984</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007323</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129985</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007347</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129986</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007354</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>ASPAVELI® enFuse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129987</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:43.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007415</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>CirCLIQ®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30130000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:48:35.758Z</lastUpdated>
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