Abiomed Inc.

Certificate 2817GB448260414

Amended

Valid until: Nov 28, 2026

Certificate 2817GB448260414 — a Quality management system issued to Abiomed Inc. — is approaching its expiry. Valid until November 28, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: 2817GB448260414
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04822817GB448260414

Validity

Issued: Apr 14, 2026
Valid from: Apr 14, 2026
Valid until: Nov 28, 2026

Manufacturer

Manufacturer: Abiomed Inc.
Manufacturer SRN: US-MF-000016855
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0482
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

2817GB448251119SupplementedNov 19, 2025 → Nov 28, 2026

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa1Class IIb1Class III1

3 scopes

MDN 1202 EMDN A030199
Class IIa
MDA 0318 EMDN Z120590
Class IIb
MDA 0318
Class III

Documents

LanguagesEN