Bien Air USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Bien Air USA, Inc. makes
Bien Air USA, Inc. manufactures surgical tools and respiratory devices, including gyroscope-based long-life surgical drills and a range of portable oxygen concentrators (e.g., BLACK PEARL ECO, ONDINE & CROMA, PRESTIGE, BORA, AQUILON, MC2, MC3). Their portfolio also includes oxygen delivery systems like the BASCH, ISOLITE, and OPTIMA, as well as compressed gas cylinders and related accessories.
The company’s devices fall under Class I regulatory classification in the U.S., with several models authorised via 510(k) clearance through the FDA. Their products are listed in the FDA 510(k) registry under Bien Air USA, Inc., and the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Orl-E-92 Surgical Drill System Ref K984244
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bien Air USA, Inc. have in the registry?
The registry currently lists 2 devices for Bien Air USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bien Air USA, Inc.'s devices?
Among its 2 most recently registered devices, Bien Air USA, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bien Air USA, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bien Air USA, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bien Air USA, Inc. in the registry?
The most recently registered devices listed for Bien Air USA, Inc. include GYRO LONG-LIFE, BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2, MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P and ORL-E-92 SURGICAL DRILL SYSTEM.