Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021006193

FEI Number

3021006193

Entity Name

NEUF Inc.

City/State/Country

Suncheon-si Jeonnam, KR

Establishment Address

#103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon, Suncheon-si Jeonnam 58034, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEUF Inc. (Owner Number: 10083419)

Owner / Operator Contact Address

#103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon, Suncheon-si, KR-46 58034, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211383

PMA Number

N/A

All Registered Proprietary Names

TOPA12 Portable X-ray Unit NFLK-2501 Portable X-ray Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2023-08-27
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2021-11-18

Official Correspondent

Woo Sang Lee

US Agent Details

Catherine Oh Email: catherine@cticert.co.kr Phone: (646) 2451153

Related Public Records

Same Entity

NEUF Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

Similar Registrations

Registration Number	Establishment Name	Location
3005246977	POSKOM CO., LTD	Goyang-si Gyeonggi, KR
3031503890	BLOCK IMAGING PARTS & SERVICE	Holt, MI, US
3011491794	ECOTRON Co., Ltd.	Seoul, KR
3007734888	WIPRO GE HEALTHCARE PRIVATE Ltd.	BANGALORE Karnataka, IN
2126677	GE MEDICAL SYSTEMS, LLC	Waukesha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021006193. Last updated year: 2026. Please use registration number 3021006193 when referencing this establishment in official correspondence.