Tietoevry Sweden AB

Certificate CR-03-1231-829-23

Rev. 03Supplemented

Valid until: Oct 27, 2028

Certificate CR-03-1231-829-23 is a valid Quality management system issued to Tietoevry Sweden AB and registered in EUDAMED. Valid until October 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: CR-03-1231-829-23
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0537CR-03-1231-829-2303

Validity

Issued: Apr 25, 2024
Valid from: Apr 25, 2024
Valid until: Oct 27, 2028

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

History

Status changes

Supplemented

Supersedes

CR-03-1231-829-23Quality management systemSupplementedNov 20, 2023 → Oct 27, 2028

Scope coverage

Class IIb2

2 scopes

MDA 0315 Software
Class IIb
NCS Cross
Class IIb

Documents

LanguagesEN