Alfa Gate Mazen L T D

FDA Filings

This page includes the latest FDA filings for Alfa Gate Mazen 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: 3013701115
• FEI Number: 3013701115
• Name: ALFA GATE - MAZEN LTD.
• Owner & Operator: alfa gate - mazen ltd.
• Contact Address: hitin st2 ; kfar qara IL-Z Ha Zafon 3007500 IL
• Official Correspondent:
  • mohamad zahalka
  • 972-4-6356686-x
• US Agent:
  • Jerry Daone
  • FDAbasics LLC
  • 716 7750533
  • jdoane@usagent-tobias.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: hitin st2 ; kfar qara Ha Zafon, 3007500 IL
• Establishment Type:
  • Foreign Private Label Distributor
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K182143 | NHA ALFA GATE - MAZEN LTD.	Alfa Gate	2019-10-08
PMN K182143 | DZE ALFA GATE - MAZEN LTD.	Alfa Gate	2019-10-08
DZA ALFA GATE - MAZEN LTD.	Alfa Gate	2019-10-08
PMN K182143 Alfa Gate Mazen Ltd	ALFA GATE Dental Implants System	2019-10-03
PMN K915375 | DZE ALFA GATE - MAZEN LTD.	Alfa Gate	2018-10-09