BrainCapture ApS

Certificate MDR-007

Rev. 1Issued

Valid until: Jan 23, 2029

Certificate MDR-007 is a valid Quality management system issued to BrainCapture ApS and registered in EUDAMED. Valid until January 23, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR-007
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1304MDR-0071

Validity

Issued: Jan 24, 2024
Valid from: Jan 24, 2024
Valid until: Jan 23, 2029

Manufacturer

Manufacturer: BrainCapture ApS
Manufacturer SRN: DK-MF-000022985
Manufacturer country: Denmark

Notified body

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Notified body SRN: 1304
Notified body country: Slovenia

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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Electroencephalography instruments
Class IIa
BC-1
Class IIa

Documents

LanguagesEN