Ceragem Medisys, Inc.
Country not established
- Devices
- 4
What Ceragem Medisys, Inc. makes
Ceragem Medisys, Inc. manufactures blood glucose monitoring systems, including the LaboNacheck Gluppy, GlucoVitaal H1A, and Cera-Chek 1070 devices. These products are designed for in vitro diagnostic use to measure glucose levels in blood samples, supporting diabetes management.
The company’s portfolio consists of Class II medical devices, authorised via the FDA’s 510(k) pathway. These devices are listed under the U.S. regulatory framework and are intended for commercial distribution within the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Glucovitaal H1A Blood Glucose Monitoring System Ref K141829
Regimes: 510(k) Registry: 510(k)Cera-Chek 1070 Blood Glucose Monitoring System Ref K131727
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ceragem Medisys, Inc. have in the registry?
The registry currently lists 4 devices for Ceragem Medisys, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ceragem Medisys, Inc.'s devices?
Among its 4 most recently registered devices, Ceragem Medisys, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Ceragem Medisys, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ceragem Medisys, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ceragem Medisys, Inc. in the registry?
The most recently registered devices listed for Ceragem Medisys, Inc. include LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM, GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM and CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM.