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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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HeartWare, Inc. — Manufacturer in United States

EUDAMED update: Mar 12, 2026

HI

HeartWare, Inc.

United States

All roles followed

Views by role

Sources: EUDAMED

Legal information of HeartWare, Inc.

Legal name: HeartWare, Inc.
EU VAT number: Not applicable
SRN (displayed role): US-MF-000019976
EUDAMED status: Active· registered in 2022
Registered office: Coral Sea St NE, 8200 MN 55112 Mounds View, United States

Contact details for HeartWare, Inc.

Email: rs.eudamedinquiries@medtronic.com
Address: 8200 , CORAL SEA ST NE MN 55112 MOUNDS VIEW UNITED STATES

Data export

Export the 34 devices of HeartWare, Inc.

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SRNUS-MF-000019976

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32 columns included

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Medical device manufacturers in EUDAMED

Competent authority for HeartWare, Inc.

Ministerie van Volksgezondheid, Welzijn en Sport
NetherlandsContact the authority →

34Total Devices

1Basic UDI-DIs

1Certificates1 valid · 0 expiring < 12 months

31CountriesEU/EEA placements

Executives & regulatory representatives of HeartWare, Inc.

2 contacts identified

MCNAUGHTON William
Main PRRC
Hidden
BUETTNER Shelby
Deputy PRRC
Hidden

Certificates of HeartWare, Inc.

Market presence of HeartWare, Inc.

Devices placed in 31 countries

Risk categories of HeartWare, Inc.

Cartography of HeartWare, Inc.

Authorised representativeNotified bodies

BSI Group The Netherlands B.V. — 1 certificate — HeartWare, Inc.
Medtronic B.V. — represents — HeartWare, Inc.

Related documents of HeartWare, Inc.

Technical documentation

Certificate MDR 737528Rev. R001

Supplemented

Manufacturer

HeartWare, Inc.

Notified body

BSI Group The Netherlands B.V.

2797

Version

1

Valid from

7/14/2026

Valid until

8/28/2029

Catalog of HeartWare, Inc.

34 devices · 1 family

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HeartWare HVAD System34 versions

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