Identity
- Trade Name
- Impella 5.0 EUDAMED
- Device Name
- Impella 5.0 EUDAMED
- Model / Reference
- 0046-3114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502012118 EUDAMED
- Basic UDI-DI
- B-00813502012118 EUDAMED
- EMDN Code
- C99 CARDIOCIRCULATORY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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 5.0 by Abiomed, Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813502012118 | Class III | Active |
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Manufacturer
- Manufacturer
- Abiomed Inc.
- EUDAMED SRN
- US-MF-000016855
- Authorised Representative
- Abiomed Europe GmbH DE-AR-000005280
Sources (1)
- EUDAMED 3d5bf61c-2f6a-4589-b382-821e083a1f65 61 fields · synced Jun 20, 2026