EUDAMED device

ACURATE Prime™

EUDAMED device 00191506030988 · Boston Scientific Corporation

Key facts

Primary DI 00191506030988
Trade name ACURATE Prime™
Device name ACURATE Prime Loading Kit
Reference or catalog number H749396942729
Manufacturer Boston Scientific Corporation
Manufacturer SRN US-MF-000004702
Risk class Class I
EMDN code P07038002
EMDN description CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES
Legislation mdr
Implantable No
Sterile Yes
Single use Yes
Status date Aug 14, 2025

At a glance

  • No Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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