Pentax Medical A Division Of Pentax Of America Inc
Inactive in EUDAMED since 2026United Statesfrom SRN EUDAMED SRN US-MF-000042816
Inactive. This company's EUDAMED actor record is marked inactive. Check the current status before ordering.
- Devices
- 15
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- PENTAX Europe GmbHDE
Catalogue
Search and filter all 15 devicesCompany details
- EUDAMED SRN
- US-MF-000042816
- EUDAMED status
- Inactive since 2026
- EUDAMED registered name
- PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC
- Registered address
- 303, CONVENTION WAY 1, 94063-1415, REDWOOD CITY, United States
- [email protected]
- Phone
- 650-722-4189
- PRRC contact
- Gurvinder Nanda
Frequently asked questions
How many devices does PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC have in the registry?
The registry currently lists 15 devices for PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC's devices?
Among its 15 most recently registered devices, PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC has devices listed in EUDAMED (13 devices), FDA 510(k) (2 devices) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC's devices fall under?
Among its 15 most recently registered devices, the classes recorded for PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC in the registry?
The most recently registered devices listed for PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC include C2 Cryoablation(TM) System catheter, C2 CryoBalloon EndoGrip, C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge and C2 CryoBalloon(TM) System Controller.