Elixir Medical Corporation

Certificate 2024-MDR/QS-061/A

Rev. 02Supplemented

Valid until: Nov 8, 2029

Certificate 2024-MDR/QS-061/A 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: 2024-MDR/QS-061/A
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 22652024-MDR/QS-061/A02

Validity

Issued: Apr 22, 2026
Valid from: Apr 22, 2026
Valid until: Nov 8, 2029

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

2024-MDR/QS-061Quality management systemAmendedApr 3, 2025 → Nov 8, 2029

Scope coverage

Class III2

2 scopes

CARDIAC ANGIOGRAPHY DEVICES - OTHER
Class III
DEVICE
Class III

Documents

LanguagesEN