Medisense, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Medisense, Inc. makes
Medisense, Inc. manufactures blood glucose monitoring systems, including test strips, meters, and data management tools for diabetes management, such as the Precision A1C Home HbA1c Kit and the MediSense Pen 2/Companion 2 system. The company also produces point-of-care devices like the Satellite A for blood acetaminophen monitoring and the Satellite C for cholesterol monitoring, alongside standalone blood glucose testers like the QuickPro and Exactech RSG systems. Additional offerings include ketone and glucose test strips, as well as advanced diabetes management tools like the Precision Xtra system.
These devices are regulated under the FDA’s 510(k) pathway, with classifications spanning Class I and Class II. The portfolio is listed in the FDA’s 510(k) clearance registry, and the company is based in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Medisense, Inc. have in the registry?
The registry currently lists 15 devices for Medisense, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medisense, Inc.'s devices?
Among its 15 most recently registered devices, Medisense, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Medisense, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Medisense, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medisense, Inc. in the registry?
The most recently registered devices listed for Medisense, Inc. include PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT, MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM, SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM and PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM.