Sway Medical, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000058050 FEI 3010325634
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Sway System Ref Version 6
Regimes: CE MDR Registry: EUDAMEDGUDIDSway System Sports Plus Ref K241737
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000058050
- FDA FEI number
- 3010325634
- EUDAMED status
- Active
- EUDAMED registered name
- Sway Medical Inc
- Registered address
- OH, Dublin, United States
- Website
- www.healthyroster.com
- [email protected]
- PRRC contact
- Michael Zagorski
Frequently asked questions
How many devices does Sway Medical, Inc. have in the registry?
The registry currently lists 2 devices for Sway Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sway Medical, Inc.'s devices?
Among its 2 most recently registered devices, Sway Medical, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sway Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sway Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sway Medical, Inc. in the registry?
The most recently registered devices listed for Sway Medical, Inc. include Sway System and Sway System Sports Plus.