Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035494481

FEI Number

3035494481

Entity Name

EDENLUX CORP.

City/State/Country

Seoul, KR

Establishment Address

1704-ho 145 Gasandigital 1-ro, Geumcheon-gu, Seoul 08519, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EDENLUX Corp. (Owner Number: 10092393)

Owner / Operator Contact Address

1704-ho 145 Gasandigital 1-ro, Geumcheon-gu, Seoul, KR-NOTA 08519, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OTUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXR	Fixation, Vision Training, Binocular	Ophthalmic	Class 1	886.1290	2025-01-01

Official Correspondent

SUNG YONG PARK

US Agent Details

Julia Kim Business: USR CO., LTD Email: ask@fdaora.com Phone: (609) 6493865

Related Public Records

Same Entity

EDENLUX Corp.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3036978613	BEIJING MINGREN SHIKANG TECHNOLOGY CO., LTD.	Beijing, CN
3015168859	NOVASIGHT	Airport City Central, IL
3009275598	WUXI ZONTAI INT'L CORPORATION LTD.	WUXI Jiangsu, CN
3041277555	OCULERA SAGLIK TEKNOLOJILERI A.S.	ANKARA, TR
3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035494481. Last updated year: 2026. Please use registration number 3035494481 when referencing this establishment in official correspondence.