<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <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>MDR 2017/745</legislation>
    <emdnCode>A05010101</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>MDR 2017/745</legislation>
    <emdnCode>A05010101</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>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30130000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:48:35.758Z</lastUpdated>
  </row>
</eudamedExport>