FDA.reportPublic FDA data

Brightheart

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30345278043034527804BRIGHTHEART SAS1N2026-01-017-11 boulevard Haussmann Paris FR 75009

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3349901758749392K251456BrightHeart View ClassifierQIH2025-06-05
3349901162843772K242342Fetal EchoScanPOK2024-11-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QIH12025-06-05
POK12024-11-14

PMN#

GUDID#