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B-Right Screen Fetal Heart

by BrightHeart

Ref FESMD01

Active European Union

CE MDR

Valid until

1 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Scarlet NB B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberSCAR-21.2.1.1 Date11 Aug 2026IssuedStatusActive expires 1 Jun 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-21.2.1.1 Active Supplemented

    Quality management system EU MDR

    Certifier
    Scarlet NB B.V. 3022
    Issued
    11 Aug 2026
    Expires
    1 Jun 2031
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Fetal EchoScan (B-Right Screen Fetal Heart)
Model / Reference
FESMD01
Primary DI / UDI-DI
03760415600024
Basic UDI-DI
376041560FESMD01BC
EMDN Code
Z12080192 Prenatal diagnostic instruments - medical device software
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000044855

Other devices from Brightheart

See all devices from Brightheart →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No