Bayer Group Diagnostics
Country not established
- Devices
- 2
What Bayer Group Diagnostics makes
The company manufactures modified glucometer systems for diabetes management, including the Glucometer Elite Diabetes Care System and the Glucometer Dex Blood Glucose System, designed for self-monitoring of blood glucose levels.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates with a US-based presence.
Catalogue
Glucometer Elite Diabetes Care System (Modified) Ref K020208
Regimes: 510(k) Registry: 510(k)Glucometer Dex Blood Glucose System (Modified) Ref K020210
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bayer Group Diagnostics have in the registry?
The registry currently lists 2 devices for Bayer Group Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bayer Group Diagnostics's devices?
Among its 2 most recently registered devices, Bayer Group Diagnostics has devices listed in FDA 510(k) (2 devices).
What risk classes do Bayer Group Diagnostics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bayer Group Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bayer Group Diagnostics in the registry?
The most recently registered devices listed for Bayer Group Diagnostics include GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) and GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED).