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Wallaby Avenir™ Coil System

by Wallaby Medical United States EUDAMEDGUDID

Ref 10HFL05015Model 10 System Helical Filling Coils 5mm x 15cm, 10USC01001 Product code KRDEMDN C010402020301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06970908210495 Basic UDI-DIDate11 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06970908210495 UDI-DIDate16 Oct 2019ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

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 · GUDID · synced 24 Oct 2026

Trade Name
Avenir Coil System EUDAMED
Avenir GUDID
Generic Name
Neurovascular embolization coil
Device Name
Wallaby Avenir™ Coil System
Model / Reference
10 System Helical Filling Coils 5mm x 15cm, 10HFL05015, 10USC01001
Primary DI / UDI-DI
06970908210495, 06970908216404
Basic UDI-DI
B-06970908210495, 0697090821WCS0013H9
Direct Marketing DI
06970908216404
FDA Product Code
KRD, HCG
EMDN Code
C010402020301, Z12109001
GMDN Term
Neurovascular embolization coil
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.3300, 882.5950
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

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
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (3)

  • EUDAMED 53c5c966-e8aa-4950-93fc-c083e8e21a25 61 fields · synced 22 Oct 2026
  • FDA UDI 61364397-c565-4a16-ae52-928e10ba57a1 32 fields · synced 29 May 2026
  • EUDAMED 06970908216404|0697090821WCS0013H9 61 fields · synced 24 Oct 2026