Data / Medical devices / South Korea / Medexel Co., Ltd.

Medexel Co., Ltd.: FDA-registered device maker in Anseong-si Gyeonggi, South Korea, 3 510(k) clearances

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

Medexel Co., Ltd. is registered with the FDA (registration 3003589279) in Anseong-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 24, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003589279
Address: 252, GeumgwangOsan-Ro, Geumgwang-myeon, Anseong-si Gyeonggi, South Korea, 17535
Owner or operator: MEDEXEL CO., LTD. (9047850)
Roles: Contract manufacturer, Manufacturer
First device listed: May 15, 2008
Registered through: 2026
Brand names listed: Autokeeper®, GOOD NEIGHBOR PHARMACY, Health Mart. PHARMACY, Simpli, Sure Comfort, SureComfort Autokeeper® Safety Pen Needle, SureComfort Insulin Syringe, Top Fine Insulin Syringe and more

Devices it lists

Device	Product code	Class	Role	Source
Needle, Hypodermic, Single Lumen	FMI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer, 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
July 24, 2018	K172095	Autokeeper	FMI	Substantially Equivalent	Medexel Co.,Ltd	accessdata.fda.gov
February 2, 2016	K152410	Top Fine Pen Needle	FMI	Substantially Equivalent	Medexel Co.,Ltd	accessdata.fda.gov
March 1, 2007	K063348	TOP FINE INSULIN SYRINGE	FMF	Substantially Equivalent	Daejin Tech Medical Manufacturing Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 24, 2018. 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.