Brightheart
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000044855
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.
- Devices
- 10
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 5
- EUDAMED 3
- FDA GUDID 3
- Device classes
- FDA Class II 8
- EU Class IIa 2
- Top EMDN categories
- Identifiers
- EUDAMED SRN FR-MF-000044855
- DUNS 279036039
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
What Brightheart makes
Brightheart develops application software designed for ultrasound imaging systems, focusing on fetal monitoring and diagnostic tools. Their products include software for fetal heart rate analysis, automated fetal echo assessments, and AI-driven classification of ultrasound images to support obstetric evaluations.
The company’s portfolio consists of Class II medical devices, regulated under FDA pathways including 510(k) premarket notifications and the Unique Device Identifier (UDI) system. These products are listed in the US and comply with applicable regulatory requirements for diagnostic software in obstetrics.
Catalogue
B-Right Screen Fetal Heart Ref FESMD01
Regimes: CE MDR Registry: EUDAMED- Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
- Registry: GUDID
B-Right Views Ref BVCMD02
Regimes: CE MDR Registry: EUDAMED- Regimes: 510(k) Registry: GUDID
Fetal EchoScan (v1.1) Ref K251071
Regimes: 510(k) Registry: 510(k)Fetal EchoScan (v1.2) Ref K252294
Regimes: 510(k) Registry: 510(k)BrightHeart View Classifier Ref K243684
Regimes: 510(k) Registry: 510(k)Fetal EchoScan Ref K242342
Regimes: 510(k) Registry: 510(k)BrightHeart View Classifier Ref K251456
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- FR-MF-000044855
- DUNS number
- 279036039
- EU VAT number
- FR79918652264
- EUDAMED status
- Active
- EUDAMED registered name
- BrightHeart
- Registered address
- 7-11, Boulevard Haussmann, 75009, Paris, France
- Website
- www.brightheart.ai/
- PRRC contact
- Saramony Lebasnier
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Jun 2031
Scarlet NB B.V. 3022 1 certificate
- SCAR-21.2.1.1 Active
Quality management system EU MDR
- Issued
- 11 Aug 2026
- Expires
- 1 Jun 2031
- Reason
- Other
FDA establishments
- Brightheart SAS Paris · FR FEI 3034527804
Frequently asked questions
How many devices does Brightheart have in the registry?
The registry currently lists 10 devices for Brightheart. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brightheart's devices?
Among its 10 most recently registered devices, Brightheart has devices listed in EUDAMED (3 devices), FDA 510(k) (5 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Brightheart's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Brightheart's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Brightheart?
EUDAMED lists 1 certificate for Brightheart (quality management system) under MDR. The most recent was issued on 11 Aug 2026.
What are the newest devices from Brightheart in the registry?
The most recently registered devices listed for Brightheart include B-Right Screen Fetal Heart, B-Right Views Fetal Heart V1.x, B-Right Screen Fetal Heart V1.1.x and B-Right Views.
Which FDA establishments are linked to Brightheart?
1 FDA establishment is linked to Brightheart in the registry; they are listed on the company page.