# Brightheart

> Medical device manufacturer record on deviCERTS, compiled from public registries. Brightheart is a medical device manufacturer based in France, with 10 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II; EU Class IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/brightheart>
- Country: France (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: FR-MF-000044855
- DUNS: 279036039

## Figures

- Devices: 10
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0
- FDA establishments: 1

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA 510(k) 5, EUDAMED 3, FDA GUDID 3
- Device classes: FDA Class II 8, EU Class IIa 2
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 2 devices

## Devices

The first 10 of 10, in the order of the canonical page, which lists them all.

- [B-Right Screen Fetal Heart](https://devicerts.com/devices/b-right-screen-fetal-heart-fesmd01) · ref FESMD01 · Class IIa · EUDAMED · status: Active
- [B-Right Views Fetal Heart V1.x](https://devicerts.com/devices/b-right-views-fetal-heart-v1-x) · Class II · EUDAMED, GUDID · status: Active
- [B-Right Screen Fetal Heart V1.1.x](https://devicerts.com/devices/b-right-screen-fetal-heart-v1-1-x) · Class II · GUDID · status: Listed
- [B-Right Views](https://devicerts.com/devices/b-right-views-bvcmd02) · ref BVCMD02 · Class IIa · EUDAMED · status: Active
- [B-Right Screen Fetal Heart V1.0.0](https://devicerts.com/devices/b-right-screen-fetal-heart-v1-0-0) · Class II · GUDID · status: Active
- [Fetal EchoScan (v1.1)](https://devicerts.com/devices/fetal-echoscan-v1-1-pok) · ref K251071 · Class II · 510(k) · status: Active · decision 2025-05-02
- [Fetal EchoScan (v1.2)](https://devicerts.com/devices/fetal-echoscan-v1-2-pok) · ref K252294 · Class II · 510(k) · status: Active · decision 2025-12-08
- [BrightHeart View Classifier](https://devicerts.com/devices/brightheart-view-classifier-qih-k243684) · ref K243684 · Class II · 510(k) · status: Active · decision 2025-05-07
- [Fetal EchoScan](https://devicerts.com/devices/fetal-echoscan-pok) · ref K242342 · Class II · 510(k) · status: Active · decision 2024-11-14
- [BrightHeart View Classifier](https://devicerts.com/devices/brightheart-view-classifier-qih) · ref K251456 · Class II · 510(k) · status: Active · decision 2025-06-05

## EU certificates

- SCAR-21.2.1.1 · Quality management system · MDR · notified body Scarlet NB B.V. · issued 2026-08-11 · expires 2031-06-01 · status: supplemented

## Source and citation

- Cite as: Brightheart. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/brightheart (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/brightheart.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/brightheart
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.