Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034527804

FEI Number

3034527804

Entity Name

BRIGHTHEART SAS

City/State/Country

Paris, FR

Establishment Address

7-11 boulevard Haussmann, Paris 75009, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BrightHeart (Owner Number: 10092243)

Owner / Operator Contact Address

7-11 boulevard Haussmann, Paris, FR-75 75009, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242342

PMA Number

N/A

All Registered Proprietary Names

B-Right Screen Fetal Heart Fetal EchoScan

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2024-12-17

Official Correspondent

Christophe Gardella

US Agent Details

George Hattub Business: Medicsense USA LLC Email: ghattub@comcast.net Phone: (508) 4996116

Related Public Records

Same Entity

BrightHeart

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K251769	Precision Medical Ventures, Inc. Dba Revealdx	RevealAI-Lung	2026-01-30

Similar Registrations

Registration Number	Establishment Name	Location
3033588305	ECHOIQ LIMITED	Sydney New South Wales, AU
3029937167	SONIO	Paris, FR
3015478020	OPTELLUM LTD	Oxford Oxfordshire, GB
2518586	Philips Ultrasound LLC	Reedsville, PA, US
3017210169	BRAINOMIX LIMITED	Oxford Oxfordshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034527804. Last updated year: 2026. Please use registration number 3034527804 when referencing this establishment in official correspondence.