Boston Scientific Cardiac Diagnostic Technologies, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000015689 FEI 3009883402
- Devices
- 38
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
Search and filter all 38 devicesCompany details
- EUDAMED SRN
- US-MF-000015689
- FDA FEI number
- 3009883402
- DUNS number
- 859807815
- EU VAT number
- 80-0044217
- EUDAMED status
- Active
- EUDAMED registered name
- Boston Scientific Cardiac Diagnostic Technologies, Inc.
- Registered address
- 2900, 37th St. NW, 55901, Rochester, United States
- Website
- www.preventicesolutions.com/
- [email protected]
- PRRC contact
- Dawn Stenstrom
From the company website
BodyGuardian™ Remote Cardiac Monitors are wearable devices that collect data for physician diagnosis. Preventice is now Boston Scientific Cardiac Diagnostics.
Frequently asked questions
How many devices does Boston Scientific Cardiac Diagnostic Technologies, Inc. have in the registry?
The registry currently lists 38 devices for Boston Scientific Cardiac Diagnostic Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boston Scientific Cardiac Diagnostic Technologies, Inc.'s devices?
Among its 38 most recently registered devices, Boston Scientific Cardiac Diagnostic Technologies, Inc. has devices listed in EUDAMED (3 devices), FDA 510(k) (1 device) and FDA GUDID (37 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Boston Scientific Cardiac Diagnostic Technologies, Inc.'s devices fall under?
Among its 38 most recently registered devices, the classes recorded for Boston Scientific Cardiac Diagnostic Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Boston Scientific Cardiac Diagnostic Technologies, Inc. in the registry?
The most recently registered devices listed for Boston Scientific Cardiac Diagnostic Technologies, Inc. include BodyGuardian SP1003, BodyGuardian Connect SW1002, BodyGuardian EUBG1001 and BodyGuardian One BG3003.