EUDAMED device

SMARTFREEZE™

EUDAMED device 00191506015718 · Boston Scientific Corporation

Key facts

Primary DI 00191506015718
Trade name SMARTFREEZE™
Device name SMARTFREEZE Cryo-Console Accessories
Reference or catalog number M004CRBS6340
Manufacturer Boston Scientific Corporation
Manufacturer SRN US-MF-000004702
Risk class Class I
EMDN code C020380
EMDN description ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Oct 24, 2025

At a glance

  • Yes 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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