Cyvek, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000049483 FEI 3040600838
- Devices
- 1
- 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
Ella Ref 600-100-CE
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000049483
- FDA FEI number
- 3040600838
- EUDAMED status
- Active
- EUDAMED registered name
- Cyvek, Inc
- Registered address
- 5, Technology Drive, 06492, Wallingford, United States
- Website
- www. Bio-techne.com
- [email protected]
- Phone
- +12036262975
- PRRC contact
- Roberto Munoz
Frequently asked questions
How many devices does CYVEK, INC. have in the registry?
The registry currently lists 1 device for CYVEK, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CYVEK, INC.'s devices?
Among its 1 most recently registered device, CYVEK, INC. has devices listed in EUDAMED (1 device).
What risk classes do CYVEK, INC.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for CYVEK, INC.'s devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from CYVEK, INC. in the registry?
The most recently registered devices listed for CYVEK, INC. include Ella.