Genexel-Sein, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Genexel-Sein, Inc. makes
Genexel-Sein, Inc. manufactures automated wrist-based digital blood pressure monitors, including models BP1600, BP1650, BP1700, and BP1750, as well as combined blood glucose and blood pressure monitoring systems under the Duo-Care brand.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Full Auto Wrist Digital Blood Pressure Monitor, Models BP1600, BP1650, BP1700 And BP1750 Ref K071523
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genexel-Sein, Inc. have in the registry?
The registry currently lists 2 devices for Genexel-Sein, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genexel-Sein, Inc.'s devices?
Among its 2 most recently registered devices, Genexel-Sein, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Genexel-Sein, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Genexel-Sein, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genexel-Sein, Inc. in the registry?
The most recently registered devices listed for Genexel-Sein, Inc. include FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 and DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM.