PixelData SRL

Certificate MDR-0038

Rev. 1Issued

Valid until: Apr 9, 2031

Certificate MDR-0038 is a valid Quality management system issued to PixelData SRL and registered in EUDAMED. Valid until April 9, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR-0038
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1304MDR-00381

Validity

Issued: Apr 10, 2026
Valid from: Apr 10, 2026
Valid until: Apr 9, 2031

Manufacturer

Manufacturer: PixelData SRL
Manufacturer SRN: RO-MF-000004762
Manufacturer country: Romania

Notified body

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Notified body SRN: 1304
Notified body country: Slovenia

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb3

3 scopes

Diagnostic imaging workstation
Class IIb
DICOM Workstation
Class IIb
PixelData PACS System
Class IIb

Documents

LanguagesEN