Combinostics Oy

Certificate FI22/871878

Rev. Issue 9Supplemented

Valid until: Feb 19, 2030

Certificate FI22/871878 is a valid Quality management system issued to Combinostics Oy and registered in EUDAMED. Valid until February 19, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: FI22/871878
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0598FI22/871878Issue 9

Validity

Issued: Oct 10, 2025
Valid from: Oct 11, 2025
Valid until: Feb 19, 2030

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

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: Yes
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

FI22/871878Quality management systemReissuedMar 19, 2025 → Feb 19, 2030

Scope coverage

Class IIa6

6 scopes

Medical software for clinical decision support V92 Medical device software not included in other classes
Class IIa
Medical software for automatic segmentation and quantification of human brain images V92 Medical device software not included in other classes
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN