Eisai U.S.A., Inc.
Country not established
- Devices
- 1
What Eisai U.S.A., Inc. makes
Eisai U.S.A., Inc. manufactures the TAKANE AUTO ENEMATOR, a series of devices designed for rectal irrigation and bowel cleansing. These models (1200R, G1300TR, G1300SR) are intended for medical use in clinical settings to facilitate the removal of fecal matter.
The TAKANE AUTO ENEMATOR devices fall under Class I regulation in the U.S., with each model listed via the FDA’s 510(k) pathway. The company is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Eisai U.S.A., Inc. have in the registry?
The registry currently lists 1 device for Eisai U.S.A., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eisai U.S.A., Inc.'s devices?
Among its 1 most recently registered device, Eisai U.S.A., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Eisai U.S.A., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Eisai U.S.A., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Eisai U.S.A., Inc. in the registry?
The most recently registered devices listed for Eisai U.S.A., Inc. include TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*.