EUDAMED device
Impella CP Introducer Kit
EUDAMED device 00813502011685 · Abiomed Inc.
Key facts
| Primary DI | 00813502011685 |
|---|---|
| Device name | Impella CP Introducer Kit |
| Reference or catalog number | 0052-3052/0052-0038, 0052-3053/0052-0039 |
| Model | 0052-3052, 0052-3053, 0052-3046 |
| Manufacturer | Abiomed Inc. |
| Manufacturer SRN | US-MF-000016855 |
| Risk class | Class IIa |
| EMDN code | C0502 |
| EMDN description | CARDIOVASCULAR INTRODUCER SHEATHS, VALVED |
| Legislation | mdd |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Jan 6, 2023 |
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: