<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810041650399</udiDi>
    <basicUdiDi>B-00810041650399</basicUdiDi>
    <tradeName>IMPEDE-FX RapidFill</tradeName>
    <deviceName>IMPEDE-FX RapidFill</deviceName>
    <manufacturerName>Shape Memory Medical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008157</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020209</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-FX-12X5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:54:06.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810041650047</udiDi>
    <basicUdiDi>B-00810041650047</basicUdiDi>
    <tradeName>IMPEDE-FX Embolization Plug</tradeName>
    <deviceName>IMPEDE-FX Embolization Plug, 8mm</deviceName>
    <manufacturerName>Shape Memory Medical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008157</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020209</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-FX-08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:54:03.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810041650030</udiDi>
    <basicUdiDi>B-00810041650030</basicUdiDi>
    <tradeName>IMPEDE-FX Embolization Plug</tradeName>
    <deviceName>IMPEDE-FX Embolization Plug, 6mm</deviceName>
    <manufacturerName>Shape Memory Medical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008157</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020209</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-FX-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:54:02.161Z</lastUpdated>
  </row>
</eudamedExport>