Medegen, Inc.
Country not established
- Devices
- 1
What Medegen, Inc. makes
Medegen, Inc. manufactures pressure-rated extension sets, which are designed for intravenous (IV) fluid administration and medication delivery in clinical settings. These devices connect IV bags or containers to administration lines, ensuring secure and leak-proof connections under specified pressure conditions.
The company’s products fall under FDA Class II devices and are authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
Medegen Pressure Rated Extension Sets Ref K083472
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medegen, Inc. have in the registry?
The registry currently lists 1 device for Medegen, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medegen, Inc.'s devices?
Among its 1 most recently registered device, Medegen, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Medegen, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Medegen, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medegen, Inc. in the registry?
The most recently registered devices listed for Medegen, Inc. include MEDEGEN PRESSURE RATED EXTENSION SETS.