Advanced Brain Monitoring, Inc.

Certificate 3309GB448250514

Issued

Valid until: Nov 6, 2029

Certificate 3309GB448250514 is a valid Quality management system issued to Advanced Brain Monitoring, Inc. and registered in EUDAMED. Valid until November 6, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 3309GB448250514
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04823309GB448250514

Validity

Issued: May 14, 2025
Valid from: May 14, 2025
Valid until: Nov 6, 2029

Manufacturer

Manufacturer: Advanced Brain Monitoring, Inc.
Manufacturer SRN: US-MF-000011252
Manufacturer country: United States

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: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa3

3 scopes

MDA 0204 EMDN N0101
Class IIa
MDA 0305 EMDN R9099
Class IIa
MDA 0315 EMDN Z12100592
Class IIa

Documents

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