Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004525100

FEI Number

3004525100

Entity Name

SOYAGREENTEC CO.,LTD

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

34-26, Jeyakgongdan 2-gil, Hyangnam-eup, Hwaseong-si Gyeonggi 18622, KR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device

Owner / Operator

SOYAGREENTEC CO.,LTD (Owner Number: 9062715)

Owner / Operator Contact Address

34-26, Jeyakgongdan 2-gil, Hyangnam-eup, Hwaseong-si, KR-41 18622, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K062834

PMA Number

N/A

All Registered Proprietary Names

NANOLET OSTEON

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-02-19
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2008-07-21

Official Correspondent

No official correspondent registered.

US Agent Details

UJU Krallum Business: Onbix Corp US Email: ONBIXUS@GMAIL.COM Phone: (843) 5828036

Related Public Records

Same Entity

SOYAGREENTEC CO.,LTD

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K052493	Steiner Laboratories	SOCKET GRAFT	2006-06-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3004468256	SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.	Suzhou City Jiangsu, CN
3010515547	PROMISEMED HANGZHOU MEDITECH CO.,LTD.	Hangzhou Zhejiang, CN
3012172036	TASSO INC	Seattle, WA, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL
3007384659	SIMPLE DIAGNOSTICS	Maspeth, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004525100. Last updated year: 2026. Please use registration number 3004525100 when referencing this establishment in official correspondence.