Single Pass, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000032056 FEI 3025268689
- Devices
- 3
- 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
Kronos Electrocautery Device Ref 900000SP-01
Regimes: CE MDR Registry: EUDAMEDSP Electrocautery Device (SP20) Ref K260287
Regimes: 510(k) Registry: 510(k)Kronos Electrocautery Device Ref K232805
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000032056
- FDA FEI number
- 3025268689
- EUDAMED status
- Active
- EUDAMED registered name
- SINGLE PASS INC.
- Registered address
- 105, North Pointe Dr, 92630, Lake Forest, United States
- Website
- www.singlepass.co
- [email protected]
- Phone
- +1-949-203-4879
- PRRC contact
- Ryan Breckenridge
Frequently asked questions
How many devices does Single Pass, Inc. have in the registry?
The registry currently lists 3 devices for Single Pass, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Single Pass, Inc.'s devices?
Among its 3 most recently registered devices, Single Pass, Inc. has devices listed in EUDAMED (1 device) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Single Pass, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Single Pass, Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Single Pass, Inc. in the registry?
The most recently registered devices listed for Single Pass, Inc. include Kronos Electrocautery Device and SP Electrocautery Device (SP20).