Episafe Medical Devices, Ltd.
Country not established
- Devices
- 1
What Episafe Medical Devices, Ltd. makes
Episafe Medical Devices, Ltd. manufactures the EPIGUARD, a medical device designed for gastrointestinal protection during endoscopic procedures.
The EPIGUARD is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Epiguard Ref K050188
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Episafe Medical Devices, Ltd. have in the registry?
The registry currently lists 1 device for Episafe Medical Devices, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Episafe Medical Devices, Ltd.'s devices?
Among its 1 most recently registered device, Episafe Medical Devices, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Episafe Medical Devices, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Episafe Medical Devices, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Episafe Medical Devices, Ltd. in the registry?
The most recently registered devices listed for Episafe Medical Devices, Ltd. include EPIGUARD.