EUDAMED device

Impella 5.0

EUDAMED device 00813502012118 · Abiomed Inc.

Key facts

Primary DI 00813502012118
Trade name Impella 5.0
Device name Impella 5.0
Reference or catalog number 0046-3114
Model 0046-3114
Manufacturer Abiomed Inc.
Manufacturer SRN US-MF-000016855
Risk class Class III
EMDN code C99
EMDN description CARDIOCIRCULATORY DEVICES - OTHER
Legislation mdd
Implantable No
Sterile Yes
Single use Yes
Status date Feb 22, 2022

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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