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EmboCube®

by Biosphere Medical SA 4 variants

Ref EC5050/EUModel EmboCube®

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00884450306291 Basic UDI-DIDate13 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 12 Aug 2026
  • Belgium since 12 Aug 2026
  • Bulgaria since 12 Aug 2026
  • Croatia since 12 Aug 2026
  • Cyprus since 12 Aug 2026
  • Czechia since 12 Aug 2026
  • Denmark since 12 Aug 2026
  • Estonia since 12 Aug 2026
  • Finland since 12 Aug 2026
  • France since 12 Aug 2026
  • Germany since 12 Aug 2026
  • Greece since 12 Aug 2026
  • Hungary since 12 Aug 2026
  • Iceland since 12 Aug 2026
  • Ireland since 12 Aug 2026
  • Italy since 12 Aug 2026
  • Latvia since 12 Aug 2026
  • Liechtenstein since 12 Aug 2026
  • Lithuania since 12 Aug 2026
  • Luxembourg since 12 Aug 2026
  • Malta since 12 Aug 2026
  • Netherlands since 12 Aug 2026
  • Northern Ireland since 12 Aug 2026
  • Norway since 12 Aug 2026
  • Poland since 12 Aug 2026
  • Portugal since 12 Aug 2026
  • Romania since 12 Aug 2026
  • Slovakia since 12 Aug 2026
  • Slovenia since 12 Aug 2026
  • Spain since 12 Aug 2026
  • Sweden since 12 Aug 2026
  • Türkiye since 12 Aug 2026

Last checked 29 Oct 2026.

Specification

EUDAMED

Device Name
EmboCube
Model / Reference
EmboCube®, EC5050/EU
Primary DI / UDI-DI
00884450306291
Basic UDI-DI
B-00884450306291
EMDN Code
C010402020303 Embolisation particles and microspheres
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
FR-MF-000005250

Other devices from Biosphere Medical SA

Properties

  • Sterile
  • Implantable
  • Animal Tissues

Other properties (8)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No