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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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StratusEEG — 4 UDI-DI variants, MDR (Kvikna Medical ehf)

MD Atlas
Kvikna Medical ehf

Data from EUDAMED, last updated May 24, 2026

StratusEEG

569411001QX

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Kvikna Medical ehf

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 569411001QX
Device name: StratusEEG
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Special device type: refdata.special-mdr-device-type.software
Version date: Jan 18, 2022

Manufacturer & authorised representative

Manufacturer

Name: Kvikna Medical ehf
SRN: IS-MF-000007239
Country: Iceland
Email: kvikna@kvikna.com
Phone: +3545788400

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01FSPD12PK9M1Y0AM8F1V3HER6

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Client05694110068064
Server05694110068057
Web05694110068040
Acquisition05694110068071