Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042198626

FEI Number

3042198626

Entity Name

SUN BIO CELL

City/State/Country

Seoul, KR

Establishment Address

6/F, 255 Seochojungang-ro, Seocho-gu, Seoul 06593, KR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sun Bio Cell (Owner Number: 10094326)

Owner / Operator Contact Address

6/F, 255 Seochojungang-ro, Seocho-gu, Seoul, KR-11 06593, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OCURA TitaniumCell 4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-11-24

Official Correspondent

No official correspondent registered.

US Agent Details

Grace Kim Business: JS INTERNATIONAL HOLDING Email: gracejschem@hotmail.com Phone: (310) 5983012

Related Public Records

Same Entity

Sun Bio Cell

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 3042198626. Last updated year: 2026. Please use registration number 3042198626 when referencing this establishment in official correspondence.