Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040619

FEI Number

3002808190

Entity Name

SHINA CORP.

City/State/Country

GONGJU-SI Chungnam, KR

Establishment Address

8-26, BOJEOKDONG-GIL, USEONG-MYEON,, GONGJU-SI Chungnam 32533, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHINA CORP. (Owner Number: 8040619)

Owner / Operator Contact Address

# 1005, 28, HWANGSAEUL-RO, 200 BEON-GIL, BUNDANG-GU, SEONGNAM-SI, KR-41 13595, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033794

PMA Number

N/A

All Registered Proprietary Names

UltiCare Insulin Safety Syringes Assure ID Insulin Safety Syringes Exel Disposable Syringes Ulticare SureComfort insulin pen needles Premier CareOne inControl ShinaPen Shina Safety Needle Nam illumination probe with chopper ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE SHINA SureComfort insulin syringes CareOne Premier inControl Shina Ulticare PISTON SYRINGE S'CARE SHINA Ulticare ULTI GUARD HOME INSULIN SYRINGE CONTAINER ULTICARE ULTICARE

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	2011-12-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2011-12-19
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2011-12-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-03-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2009-01-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-01-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-04-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-03-23
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2026-04-27
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2015-07-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-11-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	1998-09-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-11-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-11-03
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2009-01-29
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2020-03-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	1998-09-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	1998-09-02

Official Correspondent

Y. BANG

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 CORP.

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
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

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040619. Last updated year: 2026. Please use registration number 8040619 when referencing this establishment in official correspondence.