CARDIAWAVE SA

Certificate 2286829CE01

Rev. 0Issued

Valid until: Nov 1, 2030

Certificate 2286829CE01 is a valid Quality management system issued to CARDIAWAVE SA and registered in EUDAMED. Valid until November 1, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2286829CE01
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03442286829CE010

Validity

Issued: Nov 26, 2025
Valid from: Nov 26, 2025
Valid until: Nov 1, 2030

Notified body

Notified body: DEKRA Certification B.V.
Notified body SRN: 0344
Notified body country: Netherlands

Characteristics

Sterile: No
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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

DEVICE
Class IIb

Documents

LanguagesEN