Flen Health N V

FDA Filings

This page includes the latest FDA filings for Flen Health N V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006755863
FEI Number3006755863
NameFlen Health NV
Owner & OperatorFLEN Health SA
Contact AddressBlauwesteenstraat 87
Kontich BE-VAN Antwerpen 2550 BE
US Agent
Importing Logistics Registration
ImporterFlen Pharma sa
AddressRoute de Tr?ves 6D
Senningerberg, 2633 LUXEMBOURG
SubdivisionLU-G
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressBlauwesteenstraat 87
Kontich Antwerpen, 4354 BE
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Flen Health NV [FLEN Health SA]
Flamigel RT2019-01-09
Flen Health NV [FLEN Health SA]
F10302017-04-27
Flen Health NV [FLEN Health SA]
FLAMIGEL2007-09-12

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