Soma International, Ltd.
Hong Kong SAR ChinaFDA applicant, unverified
- Devices
- 1
What Soma International, Ltd. makes
Soma International, Ltd. manufactures the SOMA device, a Class I medical product designed for specific clinical applications.
The SOMA device is regulated under the FDA’s 510(k) pathway as a Class I product and is listed in the U.S. regulatory database.
Catalogue
Soma Ref K962725
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Soma International, Ltd. have in the registry?
The registry currently lists 1 device for Soma International, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Soma International, Ltd.'s devices?
Among its 1 most recently registered device, Soma International, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Soma International, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Soma International, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Soma International, Ltd. in the registry?
The most recently registered devices listed for Soma International, Ltd. include SOMA.