Widemed, Ltd.
IsraelFDA applicant, unverified
- Devices
- 3
What Widemed, Ltd. makes
Widemed, Ltd. develops automated sleep study scoring systems and data management tools, including the NOGA system and the Morpheus OX and Morpheus 1 platforms. These devices analyze polysomnography data to assist in diagnosing sleep disorders and streamline clinical workflows.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. Widemed, Ltd. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Morpheus Ox Ref K111314
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Widemed, Ltd. have in the registry?
The registry currently lists 3 devices for Widemed, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Widemed, Ltd.'s devices?
Among its 3 most recently registered devices, Widemed, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Widemed, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Widemed, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Widemed, Ltd. in the registry?
The most recently registered devices listed for Widemed, Ltd. include NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM, MORPHEUS OX and MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM.