Orbusneich Medical Co L T D Hong Kong

FDA Filings

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

FDA Registration(s)

• Registration Number: 3015002281
• FEI Number: 3015002281
• Name: ORBUSNEICH MEDICAL CO. LTD (HONG KONG)
• Owner & Operator: OrbusNeich Medical Co. Ltd (Hong Kong)
• Contact Address: Units 303 & 305, 3/F, Building 20E, Hong No. 27-31 Au Pui Wan Streeet; Fo Tan, N.T. HK-NA NA HK
• Official Correspondent:
  • Denise Lau
  • 852-2802-2288-x
• US Agent:
  • JIM CLOSSICK
  • ORBUSNEICH MEDICAL, INC
  • 954 7300711 6451
  • JCLOSSICK@ORBUSNEICH.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Units 303 &305, 3/F, Building 20E, Hong Kong Science Park, Shati No. 27-31 Au Pui Wan Streeet; Fo Tan, N.T. Not Applicable, NA HK
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K182360 | DQY ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Teleport Microcatheter	2019-03-14
PMN K180921 | LOX ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Sapphire II Pro	2019-03-14
PMN K180921 | LIT ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Sapphire II Pro	2019-03-14
PMN K173894 | LIT ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Jade PTA	2019-03-14
PMN K173680 | LOX ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Sapphire II Pro	2019-03-14
PMN K163114 | LOX ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Sapphire II Pro	2019-03-14
PMN K162209 | LOX ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Sapphire NC Plus	2019-03-14
PMN K103808 | LOX ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Sapphire NC	2019-03-14
PMN K103657 | LOX ORBUSNEICH MEDICAL CO. LTD (HONG KONG)	Sapphire	2019-03-14