WeDiagnostiX

Certificate 22M00016CRT01

Issued

Valid until: Jan 13, 2030

Certificate 22M00016CRT01 is a valid Quality management system issued to WeDiagnostiX and registered in EUDAMED. Valid until January 13, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 22M00016CRT01
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 191222M00016CRT01

Validity

Issued: Jan 13, 2025
Valid from: Jan 13, 2025
Valid until: Jan 13, 2030

Manufacturer

Manufacturer: WeDiagnostiX
Manufacturer SRN: FR-MF-000023186
Manufacturer country: France

Notified body

Notified body: Kiwa Assurance B.V.
Notified body SRN: 1912
Notified body country: Netherlands

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

MDA 0315 Software
Class IIa
WeDiagnostiX API
Class IIa

Documents

LanguagesEN