Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017717188

FEI Number

3017717188

Entity Name

YONG CHANG CO., LTD.

City/State/Country

Gimpo Gyeonggi, KR

Establishment Address

16, Hwanggeum-Ro 292beon-Gil, Yangchon-Eup, Gimpo Gyeonggi 10049, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

YONG CHANG Co., Ltd. (Owner Number: 10078365)

Owner / Operator Contact Address

16, Hwanggeum-ro 292beon-gil, Yangcheon-eup, Gimpo-si, KR-41 10049, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PRIME SYRINGE SHARP NEEDLES MINT MICROCANNULA OSG CANNULA SHARP NEEDLE PD NANO CANNULA SHARP NEEDLES DermiSync PD NANO NEEDLES SHARP NEEDLES PRIME SYRINGE PRIME SYRINGE MINT MICROCANNULA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-08-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-08-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-08-19
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2020-10-26
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-07-29
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2020-10-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-12-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-09-14
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-09-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-09-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-09-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-07-29

Official Correspondent

SANG JIN LEE

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

YONG CHANG 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
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
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

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

Similar Registrations

Registration Number	Establishment Name	Location
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3015528193	Almac Pharma Services (Ireland) Limited	Dundalk Louth, IE
3008719222	ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017717188. Last updated year: 2026. Please use registration number 3017717188 when referencing this establishment in official correspondence.