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Packing Coil 5 cm

by Penumbra, Inc. EUDAMED

Active European Union

Ref RBYPODJ5Model Embolization Coils

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 739883 Date22 Jun 2026IssuedStatusActive expires 28 Mar 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 739883 Active Supplemented

    Technical documentation EU MDR

    Notified body
    2797
    Issued
    22 Jun 2026
    Expires
    28 Mar 2028
    Reason
    Other

Specification

EUDAMED

Device Name
Penumbra Embolization Coil System
Model / Reference
Embolization Coils, RBYPODJ5
Primary DI / UDI-DI
00815948024694
Basic UDI-DI
081454801PCOEU
EMDN Code
C010402020301 Embolisation coils
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000008514
Authorised representative
Penumbra Europe GmbH DE-AR-000004997

Other devices from Penumbra, Inc.

See all devices from Penumbra, Inc. →

Properties

  • Sterile
  • Implantable
  • CMR Substance

Other properties (10)

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