Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616814

FEI Number

3003024060

Entity Name

SOOIL DEVELOPMENT CO., LTD.

City/State/Country

Yongin-si Gyeonggi, KR

Establishment Address

62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si Gyeonggi 16922, KR

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SOOIL DEVELOPMENT CO., LTD. (Owner Number: 9041551)

Owner / Operator Contact Address

62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, KR-41 16922, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063126

PMA Number

N/A

All Registered Proprietary Names

DANA DIABECARE II INSULIN PUMP DANA DIABECARE INSULIN PUMP DANA DIABECARE IIS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2008-01-16
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2008-01-16
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2008-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Jong Hyun Kim Business: SOOIL LLC Email: jeremy@sooilusa.com Phone: (858) 4040741

Related Public Records

Same Entity

SOOIL DEVELOPMENT 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
K082590	Lifescan, Inc.	SYMPHONY METER REMOTE	2008-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2013	Animas Corporation	2	IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Z-0010-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 712
Z-0011-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 512

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3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616814. Last updated year: 2026. Please use registration number 9616814 when referencing this establishment in official correspondence.