Farapulse Inc
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000017969
Farapulse Inc is a medical device manufacturer based in the United States, with 14 devices listed in EUDAMED and FDA PMA (EU Class IIb and III; FDA Class III) as of 14 Nov 2026.
- Devices
- 14
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 13
- FDA PMA 1
- Device classes
- EU Class IIb 10
- EU Class III 3
- FDA Class III 1
- Top EMDN categories
- Sites and related companies
- ICON (LR) Limited authorised representative
- Identifiers
- EUDAMED SRN US-MF-000017969
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- ICON (LR) LimitedIE
What Farapulse Inc makes
Farapulse Inc manufactures implantable cardiac devices, including pacemakers and implantable cardioverter-defibrillators (ICDs) under the FARADRIVE™ and FARASTAR™ brands. These devices are designed to manage arrhythmias by delivering pacing and shock therapies to restore normal heart rhythms. The company also produces external cardiac monitoring systems under the FARAWAVE™ brand, intended for real-time cardiac rhythm analysis and remote patient monitoring.
The company’s devices are classified as Class III and Class IIb under regulatory frameworks, with some products authorised via the FDA’s Premarket Approval (PMA) process and listed in the EU’s EUDAMED database. Farapulse Inc is headquartered in the United States.
Catalogue
Search and filter all 14 devicesCompany details
- EUDAMED SRN
- US-MF-000017969
- EUDAMED status
- Active
- EUDAMED registered name
- Farapulse Inc
- Registered address
- 3715 Haven Ave., 94025, Menlo Park, United States
- Website
- BostonScientific.com
- facebook.com/BostonScientific
- Phone
- +1 763-213-2406
- PRRC contact
- Nicole Ledder
From the company website
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
Frequently asked questions
How many devices does Farapulse Inc have in the registry?
The registry currently lists 14 devices for Farapulse Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Farapulse Inc's devices?
Among its 14 most recently registered devices, Farapulse Inc has devices listed in EUDAMED (13 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Farapulse Inc's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Farapulse Inc's devices are Class IIb and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Farapulse Inc in the registry?
The most recently registered devices listed for Farapulse Inc include FARADRIVE™, FARASTAR™, FARASTAR and FARAWAVE™.