Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017608802

FEI Number

3017608802

Entity Name

KBBIO CO., LTD.

City/State/Country

Seongnam Gyeonggi, KR

Establishment Address

165 Sunhwan-ro, Jungwon-gu, Seongnam Gyeonggi 13207, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KBBIO Co., Ltd. (Owner Number: 10078362)

Owner / Operator Contact Address

165 Sunhwan-ro, Jungwon-gu, Seongnam, KR-41 13207, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN220052

PMA Number

N/A

All Registered Proprietary Names

Vaginal Hydrogel Packing System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QXR	Vaginal Hydrogel Packing System	Radiology	Class 2	892.5735	2026-06-17

Official Correspondent

Seyeoul Park

US Agent Details

Won Lee Business: YTS Global Inc Email: wonlee@ytsglobal.com Phone: (703) 3408178

Related Public Records

Same Entity

KBBIO 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 3017608802. Last updated year: 2026. Please use registration number 3017608802 when referencing this establishment in official correspondence.