Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004458481

FEI Number

3004458481

Entity Name

SHINA MED CORPORATION

City/State/Country

Anseong-si Gyeonggi, KR

Establishment Address

455-30, Bogaewonsam-ro, Bogae-myeon, Anseong-si Gyeonggi 17509, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHINA MED CORPORATION (Owner Number: 10048989)

Owner / Operator Contact Address

455-30, Bogaewonsam-ro, Bogae-myeon, Anseong-si, KR-41 17509, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sure-Fine Insulin Syringes Shina Syringe, Shina Safety Syringe SureSwab (SureSwab NP, SureSwab OP, SureSwab Dual) Sure-Fine Insulin Syringes ULTICARE DISPOSABLE SYRINGES AND NEEDLES SureFine Pen Needle ULTICARE SAFETY INSULIN SYRINGE Sure-Fine Insulin Syringes SureFine Pen Needle DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-11-25
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2024-02-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-02-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-02-21
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-02-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-09-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-09-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-09-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-03-05
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-09-01
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2016-09-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-09-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-07-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-06-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-09-01

Official Correspondent

Kye Chae Jung

US Agent Details

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

Related Public Records

Same Entity

SHINA MED CORPORATION

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
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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004458481. Last updated year: 2026. Please use registration number 3004458481 when referencing this establishment in official correspondence.