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Thoratec® HeartMate II®

by Thoratec Corporation 5 variants

Ref 104912

Active European Union

CE AIMDD

Valid until

Not listed

EUDAMED holds no validity date

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00813024010821 Basic UDI-DI 00813024010821UDI-DIDate25 Sep 2026RegisteredStatusActive

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  • Withdrawn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/AIMDD Active

Specification

EUDAMED

Device Name
HeartMate II LVAS Implant Kit
Model / Reference
104912
Primary DI / UDI-DI
00813024010821
Basic UDI-DI
B-00813024010821
EMDN Code
J01030102 Implantable left monoventricular assistance systems (lvad)
Device Class
Class AIMDD
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000010045
Authorised representative
St. Jude Medical Coordination Center BE-AR-000008417

Other devices from Thoratec Corporation

See all devices from Thoratec Corporation →

Properties

  • Implantable

Other properties (12)

  • Sterile: 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