Mie America Inc

FDA Filings

This page includes the latest FDA filings for Mie America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Mie America Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1423348
FEI Number3000210013
NameMIE AMERICA, INC.
Owner & OperatorMIE GMBH
Contact AddressHauptstrasse 112 --
Seth DE-NOTA 23845 DE
Official Correspondent
  • Thomas - Kuehl
  • 011-494-19499770-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address420 BENNETT RD.
ELK GROVE VILLAGE, IL 60007 US
Establishment TypeRemanufacture Medical Device

FDA Filings

Device
Company
DeviceDate
MIE AMERICA, INC. [MIE GMBH]
MIE - SD-X 37 SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - ORBITER SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - MULTISPECT 3 SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - MULTISPECT 2 SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - LFOV SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - GE-XR/T SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - GE-AC/T) SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - DIACAM SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - BODYSCAN SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - SD-X 37 SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - ORBITER SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - MULTISPECT 3 SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - MULTISPECT 2 SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - LFOV SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - GE-XR/T SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - GE-AC/T) SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - DIACAM SCINTRON2007-12-05
MIE AMERICA, INC. [MIE GMBH]
MIE - BODYSCAN SCINTRON2007-12-05
MIE AMERICA, INC.
MIE - GAMMA CAMERA SYSTEMS2006-01-27
MIE AMERICA, INC. [MIE GMBH]
SCINTRON1998-07-20
MIE AMERICA, INC. [MIE GMBH]
STANDARD NUCLEAR SCANNING BED1998-07-20

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020050547819Stadersand,Federal Republic of Germany -> Norfolk, VirginiaECAT SCINTRON PET WORKINGSTATION SERIAL-NO. 2 397/REGISTRATI ON3005128583 PET SCANNER TYPE ECAT EXACT 47 PET SCANNER TYPE ECAT8 PKG
2019092046427Bremerhaven,Federal Republic of Germany -> Miami, FloridaSCANNER FOR MEDICINE DIAGNOSTIC2 PKG
2019081049335Bremerhaven,Federal Republic of Germany -> Miami, Florida1 X PET-SCANNER TYPE ECAT EXACT 47 ( MODEL NO ET (SN 2019/026) FOR THE MEDICINE DIAGNOSTIC2 PKG
201906221310Bremerhaven,Federal Republic of Germany -> Port Everglades, Florida1X PET-SCANNER TYPE ECAT EXACT 47 FOR THE MED .2 PKG
2019052157461Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyDIV. ACCESSORIES FOR TRADE SHOWS 7X COINCIDEN OSTIC5 PKG
2019042930750Bremerhaven,Federal Republic of Germany -> Port Everglades, Florida1X PET-SCANNER TYPE ECAT EXACT 47 FOR THE MED .2 PKG
2019040325927Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina1 X PET-SCANNER TYPE ECAT EXACT HR+ (SN 01010 HE NUCLEAR MEDICINE DIAGNOSTIC2 PKG
2019021327551Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaPET-SCANNER FOR NUCLEAR MEDICINE DIAGNOSTIC2 PKG
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