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HeartWare HVAD System

by HeartWare, Inc. 10 variants

Ref 1440

Active European Union

CE MDR

Valid until

28 Aug 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 737528 Date10 Aug 2026IssuedStatusActive expires 28 Aug 2029

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 737528 Active Supplemented Removed from EUDAMED

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    28 Jul 2026
    Expires
    28 Aug 2029
    Reason
    Change approved
  • MDR 737528 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    10 Aug 2026
    Expires
    28 Aug 2029
    Reason
    Change approved

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED

Device Name
HeartWare HVAD System
Model / Reference
1440
Primary DI / UDI-DI
00763000923563
Basic UDI-DI
0763000B000092489
EMDN Code
J01030102 Implantable left monoventricular assistance systems (lvad)
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000019976
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Heartware Inc.

See all devices from Heartware Inc. →

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