EUDAMED device
Automated Impella Controller
EUDAMED device 00813502010961 · Abiomed Inc.
Key facts
| Primary DI | 00813502010961 |
|---|---|
| Device name | Automated Impella Controller |
| Reference or catalog number | 0042-0010-EU, 0042-0040-EU |
| Model | 0042-0010, 0042-0040 |
| Manufacturer | Abiomed Inc. |
| Manufacturer SRN | US-MF-000016855 |
| Risk class | Class IIb |
| EMDN code | Z12059099 |
| EMDN description | VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 6, 2023 |
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: