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B-Right Views Fetal Heart V1.x

by Brightheart

Ref BVCMD01

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier Scarlet NB B.V.

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberSCAR-21.2.1.1 Date11 Aug 2026IssuedStatusWithdrawn expires 1 Jun 2031
United StatesGUDID listing GUDID Number03760415600031 UDI-DI Date13 Oct 2025ListedStatusListed GUDID: in commercial distribution

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
B-Right Views Fetal Heart
Generic Name
Ultrasound imaging system application software
Device Name
BrightHeart View Classifier (B-Right Views Fetal Heart)
Model / Reference
BVCMD01 EUDAMED
V1.x GUDID
Primary DI / UDI-DI
03760415600031
Basic UDI-DI
376041560BVCMD01AM
510(k) Number
FDA Product Code
QIH
EMDN Code
Z12080192 Prenatal diagnostic instruments - medical device software
GMDN Term
Ultrasound imaging system application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BVCMD01
GUDID
V1.x
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Brightheart

See all devices from Brightheart →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No