FDA.reportPublic FDA data

GC EUROPE N.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037755343003775534GC EUROPE N.V.1N2026-01-01Researchpark Haasrode - Leuven 1240 Interleuvenlaan 33 LEUVEN Vlaams Brabant BE 3001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105101382721893K980695FUJI IEMA1998-04-13
105101321255770K946100FUJI DUETEMA1995-01-20
105101696103459K193113GC Temp PrintEBG2020-07-09
105101330170294K182854GC FujiCEM 2 (Improved)EMA2019-07-11
105101794430159K092020AADVA ZR COLORING LIQUIDEIH2009-09-29
105101629358450K082740GC AADVA ZR DISKEIH2008-11-26
105101489105514K040567GC INITIAL MC, AL AND LFEIH2004-04-22
105101960699939K023751EXAJETELW2003-01-22
105101028893343
105102072797307

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EIH52009-09-29
EMA42019-07-11
ELW22003-01-22
EBG12020-07-09