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Wallaby Avenir™ Coil System

by Wallaby Medical EUDAMEDGUDID

Active European Union and United States

Ref 10CFN01503Model 10 System Complex Finishing Coils 1.5 mm x 3cm, 10USC01001

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 807342 Date20 Aug 2026IssuedStatusActive expires 22 Jul 2030
European UnionCE/MDD EUDAMED NumberB-06970908210945 Basic UDI-DIDate13 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06970908210945 UDI-DIDate30 Apr 2021ListedStatusIn 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 AmericaGermanyGermany
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

EU market availability

Made available in 1 country, as listed in EUDAMED:

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

  • Germany since 1 Oct 2025

Last 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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Avenir Coil System EUDAMED
Avenir GUDID
Generic Name
Neurovascular embolization coil
Device Name
Wallaby Avenir™ Coil System
Model / Reference
10 System Complex Finishing Coils 1.5 mm x 3cm, 10CFN01503, 10USC01001
Primary DI / UDI-DI
06970908210945, 06970908216855
Basic UDI-DI
B-06970908210945, 0697090821WCS0013H9
Direct Marketing DI
06970908216855
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

  • 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