EUDAMED device
Impella 5.5 with SmartAssist Set
EUDAMED device 00813502011630 · Abiomed, Inc.
Key facts
| Primary DI | 00813502011630 |
|---|---|
| Trade name | Impella 5.5 with SmartAssist Set |
| Device name | Impella 5.5 with SmartAssist Set |
| Reference or catalog number | 0550-0002 |
| Model | 0550-0002 |
| Manufacturer | Abiomed, Inc. |
| Manufacturer SRN | US-PR-000019604 |
| Risk class | Class III |
| EMDN code | C99 |
| EMDN description | CARDIOCIRCULATORY DEVICES - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | Yes |
| Single use | No |
| Status date | Jan 22, 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: