Fujirebio Europe N V

FDA Filings

This page includes the latest FDA filings for Fujirebio Europe 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 Number9615837
FEI Number3002608770
NameFujirebio Europe N.V.
Owner & OperatorFujirebio Diagnostics, Inc.
Contact Address201 Great Valley Parkway
Malvern PA 19355 US
Official Correspondent
  • Greg Dickson
  • x-610-2403888-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressTECHNOLOGIEPARK 6
GHENT Oost-Vlaanderen, B-9052 BE
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Fujirebio Europe N.V. [Fujirebio Diagnostics, Inc.]
TENDIGO Cat No. 804122016-12-19
Fujirebio Europe N.V. [Fujirebio Diagnostics, Inc.]
Auto LiPA 48 and Auto LIA 482014-06-04
Fujirebio Europe N.V. [Fujirebio Diagnostics, Inc.]
PROBE ARRAYS HCV 5' UTR ASR2007-10-17
Fujirebio Europe N.V. [Fujirebio Diagnostics, Inc.]
HCV Enzyme Mix (83L-IB)2007-10-17

Related Finance Registrations
NCAGE CodeB3888FUJIREBIO EUROPE NV
CAGE CodeB3888FUJIREBIO EUROPE NV
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