Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044777112

FEI Number

3044777112

Entity Name

RANiX Inc.

City/State/Country

Seoul, KR

Establishment Address

RANiX Bldg, 25, Eonju-ro 135-gil, Gangnam-gu,, Seoul 06053, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RANiX Inc. (Owner Number: 10095626)

Owner / Operator Contact Address

RANiX Bldg, 25, Eonju-ro 135-gil, Gangnam-gu,, Seoul, KR-11 06053, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RANiX Healthcare AI Radar Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJO	Fall Prevention Alarm/Sensor Combination Attached Or Unattached	General Hospital	Class 1	880.2400	2026-04-06

Official Correspondent

DAESUK YI

US Agent Details

HUICHAO LEE Business: SMB USA LLC. Email: info@smbusa.com Phone: (734) 6297552

Related Public Records

Same Entity

RANiX Inc.

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 3044777112. Last updated year: 2026. Please use registration number 3044777112 when referencing this establishment in official correspondence.