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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

HeartWare HVAD System

UDI-DI 00763000923716Basic UDI-DI 0763000B000092489

Class III · MDR · HeartWare, Inc.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR 737528

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-07-28 · Expiry 2029-08-28

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

HeartWare, Inc.

SRN US-MF-000019976

US · Mounds View

manufacturer

Authorised representative: Medtronic B.V. (NL-AR-000006050)

Related UDI-DIs

Showing 12 of 33 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/heartware-hvad-system-3716 · UDI page: /udi/00763000923716

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