Gc Europe N V

FDA Filings

This page includes the latest FDA filings for Gc 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 Number3003775534
FEI Number3003775534
NameGC EUROPE N.V.
Owner & OperatorGC America Inc.
Contact Address3737 W. 127th Street
Alsip IL 60803 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressResearchpark Haasrode - Leuven 1240 Interleuvenlaan 33
LEUVEN Vlaams Brabant, 3001 BE
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
GC EUROPE N.V. [GC America Inc.]
LD-1 Milling Machiine2011-10-10
GC EUROPE N.V. [GC America Inc.]
GC Aadva Scanner2011-10-10
GC EUROPE N.V. [GC America Inc.]
GC Aadva IOS2011-10-10
GC EUROPE N.V. [GC America Inc.]
GC Aadva IOS 2002011-10-10
GC EUROPE N.V. [GC America Inc.]
GC Aadva IOS 100P2011-10-10
GC EUROPE N.V. [GC America Inc.]
Aadva Zr Coloring Liquid2009-11-06
GC EUROPE N.V. [GC America Inc.]
GC Initial Zirconia Disk ST2009-01-12
GC EUROPE N.V. [GC America Inc.]
GC Initial Zirconia Disk HT2009-01-12
GC EUROPE N.V. [GC America Inc.]
GC Aadva Zr Disk2009-01-12
GC EUROPE N.V. [GC America Inc.]
GC Fuji I2008-01-31
GC EUROPE N.V. [GC America Inc.]
GC Fuji I CAPSULE2008-01-31
GC EUROPE N.V. [GC America Inc.]
Fuji I2008-01-31
GC EUROPE N.V. [GC America Inc.]
Initial2007-11-30
GC EUROPE N.V. [GC America Inc.]
Initial TI2007-11-30
GC EUROPE N.V. [GC America Inc.]
Initial Spectrum Stains2007-11-30
GC EUROPE N.V. [GC America Inc.]
Initial PC2007-11-30
GC EUROPE N.V. [GC America Inc.]
Initial Lustre Pastes NF2007-11-30
GC EUROPE N.V. [GC America Inc.]
Initial LiSi2007-11-30
GC EUROPE N.V. [GC America Inc.]
Initial IQ2007-11-30
GC EUROPE N.V. [GC America Inc.]
Exajet2007-11-30
GC EUROPE N.V. [GC America Inc.]
GC Pliers2001-04-14

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091080023Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC DENTICAL PRODUCTS LOADED ONTO 1 PALLET R EFERENCE 106651 - MELMENT F100X HS CODE 300641 PCS
202009108618Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC DENTICAL PRODUCTS LOADED ONTO 6 PALLETS INVOICE NO. 9400000636 - 9400000642 - 94000006 PCS
2020090320685Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC DENTICAL PRODUCTS LOADED ONTO 6 PALLETS INVOICE NO. 9400000636 - 9400000642 - 94000006 PCS
2020082825172Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC DENTICAL PRODUCTS LOADED ONTO 6 PALLETS INVOICE NO. 9400000636 - 9400000642 - 94000006 PCS
2020081856472Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC DENTICAL PRODUCTS LOADED ONTO 6 PALLETS INVOICE NO. 9400000636 - 9400000642 - 94000006 PCS
2020081582725Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC DENTICAL PRODUCTS LOADED ONTO 6 PALLETS INVOICE NO. 9400000636 - 9400000642 - 94000006 PCS
2020081446986Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC DENTICAL PRODUCTS LOADED ONTO 6 PALLETS INVOICE NO. 9400000636 - 9400000642 - 94000006 PCS
2020081363550Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC DENTICAL PRODUCTS LOADED ONTO 6 PALLETS INVOICE NO. 9400000636 - 9400000642 - 94000006 PCS

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