BrainU Co.,Ltd.

Certificate 2026-MDR/QS-040

Rev. 00Issued

Valid until: Jun 29, 2031

Certificate 2026-MDR/QS-040 is a valid Quality management system issued to BrainU Co.,Ltd. and registered in EUDAMED. Valid until June 29, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 2026-MDR/QS-040
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652026-MDR/QS-04000

Validity

Issued: Jun 29, 2026
Valid from: Jun 29, 2026
Valid until: Jun 29, 2031

Manufacturer

Manufacturer: BrainU Co.,Ltd.
Manufacturer SRN: KR-MF-000033438
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

CAIs SensorClass I
88001313CAIs-001EW

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I2

2 scopes

EEG CORTICAL ELECTRODES
Class I
DEVICE
Class I

Documents

LanguagesEN