Identity
- Trade Name
- Impella 5.5 with SmartAssist Set EUDAMED
- Device Name
- Impella 5.5 with SmartAssist Set EUDAMED
- Model / Reference
- 0550-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502011630 EUDAMED
- Basic UDI-DI
- 08135020116323 EUDAMED
- EMDN Code
- C99 CARDIOCIRCULATORY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Impella 5.5 with SmartAssist Set is a cardiovascular support system for patients with reduced left ventricular function. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Impella 5.5 with SmartAssist Set by Abiomed, Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08135020116323 | Class III | Active |
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Manufacturer
- Manufacturer
- Abiomed, Inc.
- EUDAMED SRN
- US-PR-000019604
Sources (1)
- EUDAMED 9803afc9-ceb5-4ccf-81ea-4d956c299409 61 fields · synced Jun 18, 2026