Medexel Co L T D

FDA Filings

This page includes the latest FDA filings for Medexel Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003589279
• FEI Number: 3003589279
• Name: Peter Chung
• Owner & Operator: MEDEXEL CO., LTD.
• Contact Address: 252, GeumgwangOsan-Ro, Geumgwang-myeon ; Anseong-si KR-41 Gyeonggido 17535 KR
• Official Correspondent:
  • Hee Nam KIM
  • 82-31-2991084-x
• US Agent:
  • Peter Chung
  • Plus Global
  • 412 5128802
  • peterchung210@gmail.com
• Importing Logistics Registration:
  • Importer: ALLISON MEDICAL, Inc.
  • Address: 8091 Shaffer Parkway ; Littleton, CO 80127 UNITED STATES
  • Email Address: info@allisonmedical.com
  • Phone: 1 880 8661618
  • Importer Type: AGENT
• Importing Logistics Registration:
  • Importer: NIPRO MEDICAL CORPORATION
  • Address: 3150 N.W.107th Avenue - ; Miami, FL 33172 UNITED STATES
• Importing Logistics Registration:
  • Importer: UltiMed Inc.
  • Address: 350 Hiway 7, Suite 100 ; Excelsior, MN 55331 UNITED STATES
  • Email Address: j.erickson@ultimedinc.com
  • Phone: 1 651 2917909
  • Importer Type: AGENT
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 300 Atwood sSt. ; Pittsburgh, PA 15213 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 28809445831295 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831533 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831526 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831519 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831502 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831496 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831489 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831472 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831465 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831458 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831441 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831434 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831410 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831403 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831397 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831380 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831373 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831366 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831359 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831342 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831335 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831328 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831311 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 18809445831304 MEDEXEL CO.,LTD.	Autokeeper	2020-05-21
GUDID 28809445832094 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445832073 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445832011 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445832004 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831991 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831984 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831977 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831960 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831953 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831946 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831939 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831922 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831915 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831908 MEDEXEL CO.,LTD.	WellFine®	2019-10-23
GUDID 18809445831885 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831878 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831854 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831847 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831830 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831823 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831816 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831809 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831793 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831786 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 18809445831779 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
GUDID 08809445831895 MEDEXEL CO.,LTD.	TopFine®	2019-10-23
PMN K172095 | FMI Peter Chung [MEDEXEL CO., LTD.]	Safety Pen Needle	2018-10-29
PMN K172095 | FMI Peter Chung [MEDEXEL CO., LTD.]	Autokeeper?	2018-10-29
PMN K172095 | FMI Peter Chung [MEDEXEL CO., LTD.]	Autokeeper? Safety Pen Needle	2018-10-29
PMN K172095 MedExel Co.,Ltd.	Autokeeper	2018-07-24
PMN K113186 | FMI Peter Chung [MEDEXEL CO., LTD.]	Sure Comport	2016-02-23
PMN K113186 | FMI Peter Chung [MEDEXEL CO., LTD.]	GLOBAL	2016-02-23
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	WellFine?	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	UltiCare?	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	Top Fine?	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	SureComfort Freedom	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	Sure Comfort	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	SunMart	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	NIPRO MEDICAL CORPORATION	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	KLINION? Soft fine? plus	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	Health Mart	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	GNP	2016-02-15
PMN K152410 | FMI Peter Chung [MEDEXEL CO., LTD.]	Caresens	2016-02-15
PMN K152410 MEDEXEL CO., LTD.	Top Fine Pen Needle	2016-02-02
PMN K063466 | FMI Peter Chung [MEDEXEL CO., LTD.]	Top Fine	2008-05-15
PMN K063348 | FMF Peter Chung [MEDEXEL CO., LTD.]	Top Fine	2008-05-15
PMN K043419 | MEG Peter Chung [MEDEXEL CO., LTD.]	P&P Safety Syringe	2008-04-25
PMN K895768 | FOZ Peter Chung [MEDEXEL CO., LTD.]	EXEL SAFELET CATHETER	2008-04-04
PMN K861153 | FMF Peter Chung [MEDEXEL CO., LTD.]	HYPODERMIC NEEDLES	2008-04-04
PMN K861153 | FMF Peter Chung [MEDEXEL CO., LTD.]	DISPOSABLE SYRINGES AND	2008-04-04
PMN K861152 | FMI Peter Chung [MEDEXEL CO., LTD.]	EXEL VACUUM BLOOD COLLECTING SYSTEM	2008-04-04
PMN K861152 | FMH Peter Chung [MEDEXEL CO., LTD.]	EXEL VACUUM BLOOD COLLECTING SYSTEM	2008-04-04
PMN K011757 | FMI Peter Chung [MEDEXEL CO., LTD.]	PEN NEEDLE	2008-04-04
PMN K011757 | FMI Peter Chung [MEDEXEL CO., LTD.]	EXEL COMFORTPOINT INSULIN	2008-04-04
PMN K011754 | MEG Peter Chung [MEDEXEL CO., LTD.]	EXEL SECURE TOUCH SAFETY SYRINGE	2008-04-04
PMN K011754 | FMI Peter Chung [MEDEXEL CO., LTD.]	EXEL SECURE TOUCH SAFETY SYRINGE	2008-04-04
PMN K011754 | FMF Peter Chung [MEDEXEL CO., LTD.]	EXEL SECURE TOUCH SAFETY SYRINGE	2008-04-04
KYX Peter Chung [MEDEXEL CO., LTD.]	EXEL INSULIN SYRINGE	2001-09-28
GAA Peter Chung [MEDEXEL CO., LTD.]	EXEL BLOOD COLLECTION NEEDLES	2001-09-28

Similar & Related FDA Registered Companies

• MEDEXEL MEDICAL MFG. CO., LTD.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092964752	Pusan,South Korea -> Seattle, Washington	INSULIN PEN NEEDLES	437 CTN
2020070764256	Pusan,South Korea -> Seattle, Washington	INSULIN PEN NEEDLES	434 CTN
2020070754415	Pusan,South Korea -> Long Beach, California	INSULIN PEN NEEDLES	125 CTN
2020051146914	Pusan,South Korea -> Long Beach, California	NEEDLE FOR INUECTIONS	2 PKG
2020051147518	Pusan,South Korea -> Tacoma, Washington	INSULIN PEN NEEDLES	850 CTN
2020031056645	Pusan,South Korea -> Seattle, Washington	INSULIN PEN NEEDLES	842 CTN
2020010757514	Pusan,South Korea -> Seattle, Washington	INSULIN PEN NEEDLES	525 CTN
2019072960183	Pusan,South Korea -> Seattle, Washington	INSULIN PEN NEEDLES	1055 CTN