Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616157

FEI Number

3003169040

Entity Name

SHINCHANG MEDICAL CO., LTD.

City/State/Country

Gumi-si Gyeongbuk, KR

Establishment Address

144, 1gongdan-ro 6-gil, Gumi-si Gyeongbuk 39385, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHIN CHANG MEDICAL CO., LTD. (Owner Number: 9035332)

Owner / Operator Contact Address

320, GONGDAN-DONG, --, GUMI-CITY, GYEONG SANG BUK-DO, KR-NOTA 730-030, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071382

PMA Number

N/A

All Registered Proprietary Names

Profi Needle Profi Pen Needle Profi Syringe DMject Insulin Syringe SCM IV Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-10-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-10-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-11-26

Official Correspondent

Yushin Kim

US Agent Details

Gary Rich Email: gary@onepharmed.com Phone: (954) 3479514

Related Public Records

Same Entity

SHIN CHANG MEDICAL 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616157. Last updated year: 2026. Please use registration number 9616157 when referencing this establishment in official correspondence.