Qlrad I N T L T D

FDA Filings

This page includes the latest FDA filings for Qlrad I N T 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: 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

• Registration Number: 3010472281
• FEI Number: 3010472281
• Name: Qlrad Inc
• Owner & Operator: QLRAD International Ltd.
• Contact Address: Damsluisweg 6 ; Almere NL-FL Flevoland 1332 EC NL
• Official Correspondent:
  • Arjen Winkel
  • 31-85-0490888-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 80 SW 8th street, suite 2000 ; Miami, FL 33130 US

FDA Filings

Device Company	Device	Date
GUDID 08720892233035 QLRAD INTERNATIONAL LTD	QLRAD	2024-04-09
GUDID 08720892233004 QLRAD INTERNATIONAL LTD	QLRAD	2024-04-09
GUDID 08719326258287 QLRAD INTERNATIONAL LTD	QLRAD	2021-09-22
GUDID 08719326258256 QLRAD INTERNATIONAL LTD	QLRAD	2021-09-22
GUDID 08719326258218 QLRAD INTERNATIONAL LTD	QLRAD	2020-10-06
PMN K180478 | PCT EA Winkel [QLRAD International Ltd.]	Endorectal balloon	2018-11-19
PMN K180478 QLRAD International Ltd.	RectalPro 75 Endorectal Balloon	2018-11-13
PMN K112057 | FMI EA Winkel [QLRAD International Ltd.]	Syringe	2013-08-29
PMN K112057 | FMF EA Winkel [QLRAD International Ltd.]	Syringe	2013-08-29