Ea Winkel

FDA Filings

This page includes the latest FDA filings for Ea Winkel. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006948745
• FEI Number: 3006948745
• Name: EA Winkel
• Owner & Operator: QLRAD International Ltd.
• Contact Address: Damsluisweg 6 ; Almere NL-FL Flevoland 1332 EC NL
• Official Correspondent:
  • Arjen Winkel
  • 31-85-0490888-x
• US Agent:
  • EA Winkel
  • QLRAD Inc
  • 305 4378550
  • awinkel@qlrad.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: at HYH 9107 NW 105th Way ; Medley, FL 33178 US
• Establishment Type:
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K180478 | PCT EA Winkel [QLRAD International Ltd.]	Endorectal balloon	2018-11-19
PMN K112057 | FMI EA Winkel [QLRAD International Ltd.]	Syringe	2013-08-29
PMN K112057 | FMF EA Winkel [QLRAD International Ltd.]	Syringe	2013-08-29

Similar & Related FDA Registered Companies

• QLRAD Inc