Applied Diabetes Research, Inc.
Country not established
- Devices
- 1
What Applied Diabetes Research, Inc. makes
Applied Diabetes Research, Inc. manufactures insulin infusion reservoir systems, including the THINSET 1.8 mL and 3.0 mL reservoirs (models 326A and 332A). These devices are designed for continuous subcutaneous insulin delivery in diabetes management, providing precise dosing via external insulin pumps.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The reservoirs are intended for use in the United States, where compliance with FDA requirements ensures their safety and performance for insulin administration.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Applied Diabetes Research, Inc. have in the registry?
The registry currently lists 1 device for Applied Diabetes Research, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Applied Diabetes Research, Inc.'s devices?
Among its 1 most recently registered device, Applied Diabetes Research, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Applied Diabetes Research, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Applied Diabetes Research, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Applied Diabetes Research, Inc. in the registry?
The most recently registered devices listed for Applied Diabetes Research, Inc. include THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A.