Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015384814

FEI Number

3015384814

Entity Name

SUNGKWANG MEDITECH., CO., LTD

City/State/Country

Yangju-si Gyeonggi, KR

Establishment Address

1014-20, Bukhansan-ro, Jangheung-myeon, Yangju-si Gyeonggi 11523, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SungKwang Meditech., Co., Ltd (Owner Number: 10088931)

Owner / Operator Contact Address

1014-20, Bukhansan-ro, Jangheung-myeon, Yangju-si, KR-41 11523, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gel Pad Snow Pac (Bean Bag) Position Pad Radiation Protection Aprons Silicon Rod & Mat Instrument Sterilization Cases

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2023-10-23
IWO	Apron, Protective	Radiology	Class 1	892.6500	2023-10-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-10-23

Official Correspondent

No official correspondent registered.

US Agent Details

Grace Kim Business: JS INTERNATIONAL HOLDING Email: ahn3060@naver.com Phone: (310) 5983012

Related Public Records

Same Entity

SungKwang Meditech., Co., Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3003495693	EMERALD NONWOVENS INTL. CO., LTD.	Phetchaburi, TH
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015384814. Last updated year: 2026. Please use registration number 3015384814 when referencing this establishment in official correspondence.