BrightHeart

Certificate SCAR-21.2.1.0

Issued

Valid until: Jun 1, 2031

Certificate SCAR-21.2.1.0 is a valid Quality management system issued to BrightHeart and registered in EUDAMED. Valid until June 1, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: SCAR-21.2.1.0
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 3022SCAR-21.2.1.0

Validity

Issued: Jun 2, 2026
Valid from: Jun 2, 2026
Valid until: Jun 1, 2031

Manufacturer

Manufacturer: BrightHeart
Manufacturer SRN: FR-MF-000044855
Manufacturer country: France

Notified body

Notified body
Notified body SRN: 3022
Notified body country: Netherlands

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 0315 - Software
Class IIa
Fetal EchoScan (B-Right Screen Fetal Heart)
Class IIa
BrightHeart View Classifier (B-Right Views Fetal Heart)
Class IIa

Documents

LanguagesEN