Data / Medical devices / South Korea / NEUF Inc.
NEUF Inc.: FDA-registered device maker in Suncheon-si Jeonnam, South Korea, 2 510(k) clearances
NEUF Inc. is registered with the FDA (registration 3021006193) in Suncheon-si Jeonnam, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021006193
- Address
- #103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon, Suncheon-si Jeonnam, South Korea, 58034
- Owner or operator
- NEUF Inc. (10083419)
- Roles
- Manufacturer
- First device listed
- November 18, 2021
- Registered through
- 2026
- Brand names listed
- NFLK-2501 Portable X-ray Unit, TOPA12 Portable X-ray Unit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 16, 2023 | K230581 | TOPA12 Portable X-ray Unit | IZL | Substantially Equivalent | Neuf, Inc. | accessdata.fda.gov |
| August 13, 2021 | K211383 | NFLK-2501 Portable X-ray Unit | IZL | Substantially Equivalent | Neuf, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.