BrainsWay Ltd.

Certificate 6106GB448251020

Issued

Valid until: Jul 15, 2028

Certificate 6106GB448251020 is a valid Quality management system issued to BrainsWay Ltd. and registered in EUDAMED. Valid until July 15, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 6106GB448251020
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04826106GB448251020

Validity

Issued: Oct 20, 2025
Valid from: Oct 20, 2025
Valid until: Jul 15, 2028

Manufacturer

Manufacturer: BrainsWay Ltd.
Manufacturer SRN: IL-MF-000029177
Manufacturer country: Israel

Notified body

Notified body
Notified body SRN: 0482
Notified body country: Germany

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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

MDA 0305 EMDN Z12101105
Class IIb

Documents

LanguagesEN