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Wallaby Avenir™ Coil System

by Wallaby Medical 110 variants

Ref 10CFR02006Model 10 System Complex Framing Coils 2mmx 6cm, 10USC01001

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

22 Jul 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 807342 Date20 Aug 2026IssuedStatusActive expires 22 Jul 2030
European UnionCE/MDD EUDAMED NumberB-06970908210198 Basic UDI-DI Date6 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06970908210198 UDI-DI Date30 Apr 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 807342 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    20 Aug 2026
    Expires
    22 Jul 2030
    Reason
    Change approved

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

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 Framing Coils 2mmx 6cm, 10CFR02006, 10USC01001
Primary DI / UDI-DI
06970908210198, 06970908216107
Basic UDI-DI
B-06970908210198, 0697090821WCS0013H9
Direct Marketing DI
06970908216107
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
EU market of registration
Germany
GUDID distribution status
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