Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010515789

FEI Number

3010515789

Entity Name

LUCEM CO., LTD.

City/State/Country

Gumi-si Gyeongbuk, KR

Establishment Address

10-167, Cheomdangieop 5-ro, Sandong-myeon, Gumi-si Gyeongbuk 39166, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LUCEM Co., Ltd. (Owner Number: 10045131)

Owner / Operator Contact Address

10-167, Cheomdangieop 5-ro, Sandong-myeon,, Gumi-si, KR-47 39166, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DXT-11L LUC-12M LUC-9M LUC-10M LUC-11M LUC-14U LUC-8M LUC-15U H1076D DXT-12M H1074D DXT-8M H1080D DXT-10M DXT-15U DXT-11M DXT-14U LUC-17U LUC-13L DXT-17U DXT-19U DXT-13L LUC-19U LUC-11L

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2013-10-23

Official Correspondent

Sung-Ho Jo

US Agent Details

WON YOUNG CHOI Business: DRGEM USA INC Email: drgemusa@gmail.com Phone: (201) 3706672

Related Public Records

Same Entity

LUCEM Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010515789. Last updated year: 2026. Please use registration number 3010515789 when referencing this establishment in official correspondence.