Sedat S.A.
Country not established
- Devices
- 2
What Sedat S.A. makes
Sedat S.A. manufactures the Dolphin Inflation Device, a medical tool designed for controlled inflation applications, and the Myshell, a protective shell or casing likely intended for medical device containment or patient isolation.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices and is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Dolphin Inflation Device Ref K042449
Regimes: 510(k) Registry: 510(k)Myshell Ref K040498
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sedat S.A. have in the registry?
The registry currently lists 2 devices for Sedat S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sedat S.A.'s devices?
Among its 2 most recently registered devices, Sedat S.A. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sedat S.A.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sedat S.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sedat S.A. in the registry?
The most recently registered devices listed for Sedat S.A. include DOLPHIN INFLATION DEVICE and MYSHELL.