Medicore Co L T D

FDA Filings

This page includes the latest FDA filings for Medicore 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: 2000010846
• FEI Number: 2000010846
• Name: ZALE ATLEY
• Owner & Operator: MEDICORE CO. LTD.
• Contact Address: 3F, Samwoo B/D, 339-2, Jamsil-dong, Songpa-gu, Seoul, KOREA; Seoul KR-11 Seoul Teugbyeolsi 138867 KR
• Official Correspondent:
  • Byung-kuk YOO
  • 82-2-2056-2650
• US Agent:
  • ZALE ATLEY
  • 512 3960138
  • BKYOO@MEDI-CORE.COM
• Importing Logistics Registration:
  • Importer: Assist Medical
  • Address: 67 35TH STREET 2ND FLOOR ; Brooklyn, NY 11232 UNITED STATES
• Importing Logistics Registration:
  • Importer: Copley Global Services LLC
  • Address: 303 Wyman St Ste 300 ; Waltham, MA 02451 UNITED STATES
  • Phone: 1 617 9665306
• Importing Logistics Registration:
  • Importer: NZ MEDICO GROUP INC.
  • Address: Suite C209 Suite C-209 ; Parsippany, NJ 07054 UNITED STATES
• Importing Logistics Registration:
  • Importer: Shop Anatomical, Inc.
  • Address: 305A Miami,St, ; West Columbia, SC 29170 UNITED STATES
• Importing Logistics Registration:
  • Importer: Sleep Center
  • Address: 2792 OCEAN AVE. UNIT 5, FLOOR 5 ; Brooklyn, NY 11229 UNITED STATES
• Importing Logistics Registration:
  • Importer: the cardio group
  • Address: 5255 W. 11000 N. Suite 225 ; Am Fork, UT 84003 UNITED STATES
• Importing Logistics Registration:
  • Importer: Zale Atley
  • Address: 411 RANCHO ENCINO DR. SAN MARCOS ; San Marcos, TX 78666 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 411 RANCHO ENCINO DR. ; San Marcos, TX 78666 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

• Registration Number: 3016511680
• FEI Number: 3016511680
• Name: MEDICORE CO., LTD.
• Owner & Operator: MEDICORE Co., Ltd.
• Contact Address: 47-13, Yongjeonggyeongje-ro 1-gil ; Pocheon-si KR-41 Gyeonggido 11154 KR
• US Agent:
  • April Lee
  • Withus Group Inc.
  • 909 2749971
  • withus6664@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 47-13, Yongjeonggyeongje-ro 1-gil ; Pocheon-si Gyeonggido, 11154 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00191237000069 Medicore Co., Ltd.	IRIS-XP IRIS	2021-11-09
PMN K212412 Medicore Co., Ltd.	IRIS-XP	2021-09-13
KAR MEDICORE CO., LTD.	Nose Sweeper Kit	2019-12-29
GUDID 10191237000011 Medicore Co., Ltd.	SA-3000P SA-3000P	2019-04-18
GUDID 40191237000036 Medicore Co., Ltd.	Max Pulse Max Pulse	2019-03-13
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	VasoScan	2012-02-02
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	Polestar 5000	2012-02-02
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	Neuro Pulse	2012-02-02
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	Max Pulse	2012-02-02
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	CardioWA	2012-02-02
PMN K110374 MEDICORE CO., LTD.	MAX PULSE SYSTEM	2011-06-13
PMN K073323 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	SA-3000P	2008-03-26
PMN K073323 MEDICORE CO., LTD.	SA-3000P	2007-11-29

Related Finance Registrations

NCAGE Code	2M57F	MEDICORE CO., LTD.
CAGE Code	2M57F	MEDICORE CO., LTD.