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ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit

by Asahi Intecc Co., Ltd. 59 variants

Ref WAIN-FBK-4AD80

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04547327098977 Basic UDI-DI 04547327098977UDI-DIDate25 Dec 2025RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Model / Reference
WAIN-FBK-4AD80
Primary DI / UDI-DI
04547327098977
Basic UDI-DI
B-04547327098977
EMDN Code
C0104020204 Peripheral angiography guide catheters
Device Class
Class III
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
JP-MF-000010199
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • 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