Elixir Medical Corporation

Certificate 2025-MDR/QS-051

Rev. 0Issued

Valid until: Nov 8, 2029

Certificate 2025-MDR/QS-051 is a valid Quality management system issued to Elixir Medical Corporation and registered in EUDAMED. Valid until November 8, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-MDR/QS-051
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652025-MDR/QS-0510

Validity

Issued: Nov 10, 2025
Valid from: Nov 10, 2025
Valid until: Nov 8, 2029

Manufacturer

Manufacturer: Elixir Medical Corporation
Manufacturer SRN: US-MF-000013041
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

DynamX Sirolimus Eluting Coronary Bioadaptor SystemClass III
081750801DynamXVIR4F

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

Vascular endoprostheses – other
Class III
DEVICE
Class III

Documents

LanguagesEN