Bionime Coporation
Country not established
- Devices
- 2
What Bionime Coporation makes
Bionime Corporation manufactures blood glucose monitoring systems, including the GE333 device, which measures glucose levels for diabetes management. The company also provides diabetes management software and adapters designed to integrate with glucose monitoring systems, supporting data tracking and connectivity.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
GE333 Blood Glucose Monitoring System Ref K143387
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bionime Coporation have in the registry?
The registry currently lists 2 devices for Bionime Coporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionime Coporation's devices?
Among its 2 most recently registered devices, Bionime Coporation has devices listed in FDA 510(k) (2 devices).
What risk classes do Bionime Coporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bionime Coporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionime Coporation in the registry?
The most recently registered devices listed for Bionime Coporation include GE333 Blood Glucose Monitoring System and RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007), RIGHTEST NEW ADAPTERS-3, GE DIABETES MANAGEM.