<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00884450306291</udiDi>
    <basicUdiDi>B-00884450306291</basicUdiDi>
    <tradeName>EmboCube®</tradeName>
    <deviceName>EmboCube</deviceName>
    <manufacturerName>Biosphere Medical SA</manufacturerName>
    <manufacturerSrn>FR-MF-000005250</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC5050/EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:44:58.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450299432</udiDi>
    <basicUdiDi>B-00884450299432</basicUdiDi>
    <tradeName>Embosphere®</tradeName>
    <deviceName>Embosphere in syringe</deviceName>
    <manufacturerName>Biosphere Medical SA</manufacturerName>
    <manufacturerSrn>FR-MF-000005250</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S020GH/EUA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:44:57.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450119761</udiDi>
    <basicUdiDi>B-00884450119761</basicUdiDi>
    <tradeName>EmboGold®</tradeName>
    <deviceName>EmboGold</deviceName>
    <manufacturerName>Biosphere Medical SA</manufacturerName>
    <manufacturerSrn>FR-MF-000005250</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S120EG/EUA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:44:56.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450112854</udiDi>
    <basicUdiDi>B-00884450112854</basicUdiDi>
    <tradeName>EmboGold®</tradeName>
    <deviceName>EmboGold</deviceName>
    <manufacturerName>Biosphere Medical SA</manufacturerName>
    <manufacturerSrn>FR-MF-000005250</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1020EG/EUA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:44:55.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450109519</udiDi>
    <basicUdiDi>B-00884450109519</basicUdiDi>
    <tradeName>Embosphere®</tradeName>
    <deviceName>Embosphere in syringe</deviceName>
    <manufacturerName>Biosphere Medical SA</manufacturerName>
    <manufacturerSrn>FR-MF-000005250</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1020GH/EUA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:44:51.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450306307</udiDi>
    <basicUdiDi>B-00884450306307</basicUdiDi>
    <tradeName>EmboCube®</tradeName>
    <deviceName>EmboCube</deviceName>
    <manufacturerName>Biosphere Medical SA</manufacturerName>
    <manufacturerSrn>FR-MF-000005250</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC50100/EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:40:23.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450306277</udiDi>
    <basicUdiDi>B-00884450306277</basicUdiDi>
    <tradeName>EmboCube®</tradeName>
    <deviceName>EmboCube</deviceName>
    <manufacturerName>Biosphere Medical SA</manufacturerName>
    <manufacturerSrn>FR-MF-000005250</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC25100/EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-11T03:49:31.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450306260</udiDi>
    <basicUdiDi>B-00884450306260</basicUdiDi>
    <tradeName>EmboCube®</tradeName>
    <deviceName>EmboCube</deviceName>
    <manufacturerName>Biosphere Medical SA</manufacturerName>
    <manufacturerSrn>FR-MF-000005250</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC2550/EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-11T03:49:30.795Z</lastUpdated>
  </row>
</eudamedExport>