Skip to content

HepaSphere™

by Biosphere Medical SA

Ref V225HS/CModel HepaSphere™

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00884450310588 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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
HepaSphere
Model / Reference
HepaSphere™, V225HS/C
Primary DI / UDI-DI
00884450310588
Basic UDI-DI
B-00884450310588
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
  • Administering Medicine

Other properties (7)

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