Kallisio, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000052701
- Devices
- 5
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMED
kallisio stentra™ oral stent Ref K232293
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000052701
- EUDAMED status
- Active
- EUDAMED registered name
- Kallisio Inc.
- Registered address
- 1734, Maryland Avenue, 21201, Baltimore, United States
- Website
- www.kallisio.com
- [email protected]
- PRRC contact
- Katja Krempler
Frequently asked questions
How many devices does Kallisio, Inc. have in the registry?
The registry currently lists 5 devices for Kallisio, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kallisio, Inc.'s devices?
Among its 5 most recently registered devices, Kallisio, Inc. has devices listed in EUDAMED (4 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Kallisio, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Kallisio, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kallisio, Inc. in the registry?
The most recently registered devices listed for Kallisio, Inc. include Stentra Lat-Right Intraoral Stent, Stentra Depress Intraoral Stent, Stentra Elevate Intraoral Stent and Stentra Lat-Left Intraoral Stent.