Ascensia Diabetes Care
Country not established
- Devices
- 6
What Ascensia Diabetes Care makes
Ascensia Diabetes Care manufactures blood glucose monitoring systems, including portable meters, USB-connected devices, and wireless-enabled systems for home use. These products measure capillary blood glucose levels for individuals managing diabetes, with variations designed for ease of use and connectivity. Some models feature integrated test strips and simplified calibration processes.
The company’s portfolio is regulated under Class II medical devices in the U.S., with devices authorised via 510(k) premarket notifications to the FDA. The products are listed in the FDA’s 510(k) database as authorised devices. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
CONTOUR NEXT ONE Blood Glucose Monitoring System Ref K160682
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ascensia Diabetes Care have in the registry?
The registry currently lists 6 devices for Ascensia Diabetes Care. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ascensia Diabetes Care's devices?
Among its 6 most recently registered devices, Ascensia Diabetes Care has devices listed in FDA 510(k) (6 devices).
What risk classes do Ascensia Diabetes Care's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Ascensia Diabetes Care's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ascensia Diabetes Care in the registry?
The most recently registered devices listed for Ascensia Diabetes Care include CONTOUR® PLUS BLUE Blood Glucose Monitoring System, CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System and CONTOUR NEXT ONE Blood Glucose Monitoring System.