No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Abiomed Inc.

SRN US-MF-000016855

manufacturer · Danvers, US · 17 devices

22 Cherry Hill Drive, 01923

Devices

Name	UDI-DI	Class	Badge
Automated Impella Controller	00813502010961	Class IIb	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Axillary Insertion Graft Lock	00813502012231	Class Is	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Connector Cable	04260113630259	Class Is	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Guidewire Impella	04260113630303	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella 5.0	00813502012118	Class III	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella 5.5 with SmartAssist	00813502012071	Class III	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella CP Introducer Kit	00813502011678	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella CP Introducer Kit	00813502011685	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella CP Introducer Kit	00813502011692	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella CP Introducer Kit	00813502011708	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella CP Introducer Kit	00813502011715	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella Purge Cassette	00813502011999	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella Purge Cassette	00813502012002	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella Purge Cassette	00813502012507	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Impella RP	00813502012033	Class III	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Incision Template	00813502012101	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Silicone Plugs	00813502012088	Class IIa	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED