Data / Medical devices / South Korea / Shina Corp.

Shina Corp.: FDA-registered device maker in GONGJU-SI Chungnam, South Korea, 13 510(k) clearances

Name: Shina Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shina Corp. is registered with the FDA (registration 8040619) in GONGJU-SI Chungnam, South Korea. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated March 20, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8040619
FEI number: 3002808190
Address: 8-26, Bojeokdong-Gil, Useong-Myeon, GONGJU-SI Chungnam, South Korea, 32533
Owner or operator: SHINA CORP. (8040619)
Roles: Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer
First device listed: September 2, 1998
Registered through: 2026
Brand names listed: Assure ID Insulin Safety Syringes, CareOne, Exel Disposable Syringes, Nam illumination probe with chopper, PISTON SYRINGE, Premier, S'CARE, SHINA and more

Devices it lists

Device	Product code	Class	Role	Source
Container, Sharps	MMK	2	Contract manufacturer	accessdata.fda.gov
Endoilluminator	MPA	2	Contract manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 20, 2023	K222417	Shina Safety Needle	FMI	Substantially Equivalent	Shina Corporation	accessdata.fda.gov
February 9, 2015	K140949	ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE	MEG	Substantially Equivalent	Ultimed Incorporated	accessdata.fda.gov
September 12, 2013	K124037	JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE	FMF	Substantially Equivalent	Jung Rim Medical Industrial Co., Ltd.	accessdata.fda.gov
April 12, 2012	K113186	STERILE INSULIN PEN NEEDLE	FMI	Substantially Equivalent	Shina Corp.	accessdata.fda.gov
February 2, 2011	K103011	ULTICARE SAFETY INSULIN SYRINGE	MEG	Substantially Equivalent	Ulti-Med Intl., Inc.	accessdata.fda.gov
August 6, 2009	K091167	SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES	FMF	Substantially Equivalent	Shina Corp.	accessdata.fda.gov
June 25, 2008	K080600	ULTIMED ULTICARE SAFETY SYRINGE	MEG	Substantially Equivalent	Ultimed, Inc.	accessdata.fda.gov
October 12, 2007	K071947	VACU-MED BLOOD COLLECTION NEEDLES	FMI	Substantially Equivalent	Shina Corp.	accessdata.fda.gov
November 29, 2006	K062702	ULTICARE DISPOSABLE SYRINGES AND NEEDLES	FMF	Substantially Equivalent	Ultimed, Inc.	accessdata.fda.gov
December 30, 2003	K033794	ULTICARE DISPOSABLE SYRINGE 3 ML/CC	FMF	Substantially Equivalent	Ultimed, Inc.	accessdata.fda.gov
March 24, 2000	K994230	ULTICARE DISPOSABLE SYRINGE	FMF	Substantially Equivalent	Ultimed, Inc.	accessdata.fda.gov
February 11, 1988	K875148	MEDICRAT, HYPODERMIC SYRINGES & NEEDLES	FMF	Substantially Equivalent	Knowltech Ind., Inc.	accessdata.fda.gov
April 23, 1986	K861153	DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES	FMF	Substantially Equivalent	Exel Intl.	accessdata.fda.gov

Compare with other makers

Updated March 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.