Elute, Inc.
United StatesFDA applicant, unverified FDA FEI 3021988499
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Registry: GUDID
BonVie+ Ref K250346
Regimes: 510(k) Registry: 510(k)EP Granules™ BVF Ref K180853
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3021988499
- DUNS number
- 968551015
- Address
- 417 S WAKARA WAY, #3510, Salt Lake City, UT, 84108
- [email protected]
- Phone
- (801)-410-4330
Frequently asked questions
How many devices does Elute, Inc. have in the registry?
The registry currently lists 3 devices for Elute, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elute, Inc.'s devices?
Among its 3 most recently registered devices, Elute, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Elute, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Elute, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elute, Inc. in the registry?
The most recently registered devices listed for Elute, Inc. include BonVie+ EPBV-10ML, BonVie+ and EP Granules™ BVF.