Tietoevry AB

Certificate CR-03-1228-849-24

Rev. 03Supplemented

Valid until: Jun 26, 2029

Certificate CR-03-1228-849-24 is a valid Quality management system issued to Tietoevry AB and registered in EUDAMED. Valid until June 26, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: CR-03-1228-849-24
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0537CR-03-1228-849-2403

Validity

Issued: Nov 25, 2024
Valid from: Nov 25, 2024
Valid until: Jun 26, 2029

Manufacturer

Manufacturer: Tietoevry AB
Manufacturer SRN: SE-MF-000037727
Manufacturer country: Sweden

Notified body

Notified body: Eurofins Electric & Electronics Finland Oy
Notified body SRN: 0537
Notified body country: Finland

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: No
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

Status changes

Supplemented

Supersedes

CR-03-1228-849-24Quality management systemSupplementedSep 23, 2024 → Jun 26, 2029

Scope coverage

Class IIa3

3 scopes

MDA 0315 Software
Class IIa
Lifecare Lab Pathology
Class IIa
FlexLab LIMS
Class IIa

Documents

LanguagesEN