Cea America Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Cea America Corp. makes
Cea America Corp. manufactures medical imaging films, including the SINGUL-XR RP non-screen medical film and various WILCOR-XR RP medical film products. The company also produces the MEDICOUNT DEKA hematology analyzer.
The company is based in the United States, and its portfolio includes devices categorized as Class I and Class II. These products are listed in the FDA 510(k) regulatory registry.
Catalogue
Singul-Xr Rp Non Screen Med. Film Ref K834611
Regimes: 510(k) Registry: 510(k)Wilcor-Xr Rp-Og Medical Film Ref K834612
Regimes: 510(k) Registry: 510(k)Wilcor-Xr Rp Medical Film Ref K834613
Regimes: 510(k) Registry: 510(k)Wilcor-Xr Rp-L Medical Film Ref K834614
Regimes: 510(k) Registry: 510(k)Medicount Deka Hematology Analyzer Ref K942525
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cea America Corp. have in the registry?
The registry currently lists 5 devices for Cea America Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cea America Corp.'s devices?
Among its 5 most recently registered devices, Cea America Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cea America Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cea America Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cea America Corp. in the registry?
The most recently registered devices listed for Cea America Corp. include SINGUL-XR RP NON SCREEN MED. FILM, WILCOR-XR RP-OG MEDICAL FILM, WILCOR-XR RP MEDICAL FILM and WILCOR-XR RP-L MEDICAL FILM.