Icare Finland Oy

Certificate FI22/00000011

Rev. Issue 5Reissued

Valid until: Oct 6, 2030

Certificate FI22/00000011 is a valid Quality management system issued to Icare Finland Oy and registered in EUDAMED. Valid until October 6, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: FI22/00000011
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI22/00000011Issue 5

Validity

Issued: Oct 7, 2025
Valid from: Oct 7, 2025
Valid until: Oct 6, 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: —
QMS/MOS type: Basic UDI-DI data only

History

Supersedes

FI22/00000011Quality management systemSupplementedAug 23, 2024 → Oct 9, 2027

Scope coverage

Class IIa9

9 scopes

Tonometers, Z12120122
Class IIa
Software accessories for Tonometers, Z12120182
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN