Vitec Codea Oy

Certificate FI24/00000055

Rev. Issue 2Amended

Valid until: Sep 2, 2027

Certificate FI24/00000055 is a valid Quality management system issued to Vitec Codea Oy and registered in EUDAMED. Valid until September 2, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: FI24/00000055
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0598FI24/00000055Issue 2

Validity

Issued: Nov 25, 2024
Valid from: Nov 25, 2024
Valid until: Sep 2, 2027

Manufacturer

Manufacturer: Vitec Codea Oy
Manufacturer SRN: FI-MF-000012142
Manufacturer country: Finland

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
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

Amended

Supersedes

FI24/00000055Quality management systemIssuedSep 3, 2024 → Sep 2, 2027

Scope coverage

Class IIa2

2 scopes

ePCR v1.2
Class IIa
Medical software for emergency patient care reporting V92 medical device SW - not included in other classes
Class IIa

Documents

LanguagesEN