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HeartWare HVAD System

by HeartWare, Inc. EUDAMED

Active European Union

Ref 1575

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 737528 Date28 Jul 2026IssuedStatusActive expires 28 Aug 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 737528 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    28 Jul 2026
    Expires
    28 Aug 2029
    Reason
    Change approved

Specification

EUDAMED

Device Name
HeartWare HVAD System
Model / Reference
1575
Primary DI / UDI-DI
00763000923624
Basic UDI-DI
0763000B000092489
EMDN Code
J01030102 Implantable left monoventricular assistance systems (lvad)
Device Class
Class III
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