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Impella 0052-3018

by Abiomed, Inc.

Ref 0052-3018

Impella 0052-3018 is a device classified as Class IIa in the EU and Class III in the US made by Abiomed, Inc., registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-04260113630327) and listed in FDA GUDID since 21 Oct 2016 (UDI-DI 04260113630327), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260113630327 Basic UDI-DI 04260113630327UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260113630327 UDI-DI Date21 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04260113630327 registered 12 Oct 2026 Active
  • FDA GUDID UDI-DI 04260113630327 listed 21 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260113630327
  2. Registered EUDAMED B-04260113630327

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Impella
Generic name
Intracardiac circulatory assist axial-pump catheter
Device name
Impella Guidewire 0.027
Model / Ref / Catalog
0052-3018
Primary DI / UDI-DI
04260113630327
Basic UDI-DI
B-04260113630327
FDA product code
OZD, DQX
EMDN code
C0480 Cardiovascular guidewires - accessories
GMDN term
Intracardiac circulatory assist axial-pump catheter
Device class
Class IIa EUDAMED
Class III GUDID
Regulation number
870.1330
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class III

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Intracardiac circulatory assist axial-pump catheter

Similar devices in this category

Other devices filed under CARDIOVASCULAR GUIDEWIRES - ACCESSORIES.

Other devices from Abiomed, Inc.

See all devices from Abiomed, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)