BRAEBON Medical Corporation

Certificate 28620214964

Rev. 02Issued

Valid until: Nov 18, 2029

Certificate 28620214964 is a valid Quality management system issued to BRAEBON Medical Corporation and registered in EUDAMED. Valid until November 18, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620214964
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862021496402

Validity

Issued: Nov 24, 2025
Valid from: Nov 24, 2025
Valid until: Nov 18, 2029

Manufacturer

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
Manufacturer country: Canada

Notified body

Notified body
Notified body SRN: 2862
Notified body country: Sweden

Covered devices

MediByteClass IIa
++B140MediByte4Q

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

Medical device software for data recording
Class IIa
Monitoring devices
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN