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Impella 5.5 with SmartAssist Set
EUDAMEDClass III (EU MDR)
Ref 1000482Ref 0550-0007
Identity
- Trade Name
- Impella 5.5 with SmartAssist Set EUDAMEDImpella 5.5 with SmartAssist EUDAMED
- Device Name
- Impella 5.5 with SmartAssist Set EUDAMEDImpella 5.5 EUDAMED
- Model / Reference
- 1000482 EUDAMED0550-0007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502013276 EUDAMED00813502012071 EUDAMED
- Basic UDI-DI
- 08135020132729 EUDAMEDB-00813502012071 EUDAMED
- EMDN Code
- C99 CARDIOCIRCULATORY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Impella 5.5 with SmartAssist Set by Abiomed, Inc. — Class III — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 08135020132729 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 08135020132729 | Class III | Active |
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Manufacturer
- Manufacturer
- Abiomed, Inc.
- EUDAMED SRN
- US-PR-000019604
Sources (2)
- EUDAMED 749e98e4-b712-462b-9ca9-89e9e3181f02 61 fields · synced Jul 21, 2026
- EUDAMED a855e538-69fd-43de-bbb1-75a059f7668c 61 fields · synced Jul 21, 2026