Neuf, Inc.
South KoreaFDA applicant, unverified
- Devices
- 4
What Neuf, Inc. makes
Neuf, Inc. manufactures portable X-ray units, including the TOPA12 and NFLK-2501 models, designed for on-site imaging applications.
These devices are classified as Class II under US regulations and are listed via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
TOPA12 Portable X-ray Unit Ref K230581
Regimes: 510(k) Registry: 510(k)NFLK-2501 Portable X-ray Unit Ref K211383
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 695621620
Frequently asked questions
How many devices does Neuf, Inc. have in the registry?
The registry currently lists 4 devices for Neuf, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neuf, Inc.'s devices?
Among its 4 most recently registered devices, Neuf, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Neuf, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Neuf, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neuf, Inc. in the registry?
The most recently registered devices listed for Neuf, Inc. include X-RAY NFLK-2501, X-RAY TOPA12, TOPA12 Portable X-ray Unit and NFLK-2501 Portable X-ray Unit.