Skip to content

Avenir Coil System

by Wallaby Medical United States EUDAMED

Ref 10USH02503Model 10USC01001 EMDN Z12109001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0697090821WCS0013H9 Basic UDI-DIDate19 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 807342 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    20 Aug 2026
    Expires
    22 Jul 2030
    Reason
    Change approved

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Wallaby Avenir™ Coil System
Model / Reference
10USC01001, 10USH02503
Primary DI / UDI-DI
06970908218149
Basic UDI-DI
0697090821WCS0013H9
Direct Marketing DI
06970908218149
EMDN Code
Z12109001 Detachable coil equipment for brain aneurysms
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000010241
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Wallaby Medical

See all devices from Wallaby Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 06970908218149|0697090821WCS0013H9 61 fields · synced 25 Oct 2026