Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013534361

FEI Number

3013534361

Entity Name

SUNBIO,INC.

City/State/Country

Incheon-si, KR

Establishment Address

129 Eunbong-ro, Namdong-gu, Incheon-si 21639, KR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

SunBio,Inc. (Owner Number: 10083497)

Owner / Operator Contact Address

129 Eunbong-ro, Namdong-gu, Incheon-si, KR-28 21639, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190144

PMA Number

N/A

All Registered Proprietary Names

MucoPEG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFD	Saliva, Artificial	Unknown	Class U	N/A	2021-11-24

Official Correspondent

Kwang Nho

US Agent Details

Terry Nho Email: terrynho.sunbio@gmail.com Phone: (925) 3305383

Related Public Records

Same Entity

SunBio,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 3013534361. Last updated year: 2026. Please use registration number 3013534361 when referencing this establishment in official correspondence.