77 Elektronika Kft

FDA Filings

This page includes the latest FDA filings for 77 Elektronika Kft. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1000369487
FEI Number1000369487
NameMike Leslie
Owner & Operator77 Elektronika Kft.
Contact AddressFehervari ut 98.
Budapest HU-BU Budapest 1116 HU
Official Correspondent
  • Oliver Babinszki
  • 36-30-3821901-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9115 Hague Rd
Indianapolis, IN 46256 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Mike Leslie [77 Elektronika Kft.]
cobas u601 urine analyzer2019-05-21
Mike Leslie [77 Elektronika Kft.]
Urisys 11002012-07-09
Mike Leslie [77 Elektronika Kft.]
Urisys 11002012-07-09

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091186427Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsURINE ANALYZER10 PKG
2020080772876Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsURINE ANALYZER10 PKG
2020071059806Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsURINE ANALYZERS11 PKG
2020060454787Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsURINE MICROSCOPY ANALYZER10 PKG
2020052946542Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsURINE MICROSCOPY ANALYZER10 PKG
2020050636896Stadersand,Federal Republic of Germany -> Boston, MassachusettsURINE MIICROSCOPY ANALYZER9 PKG
2020040342186Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsURINE ANALYZERS HS CODE90275010 PKG
2019112224392Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsMINI MICROSCOPE HS 9027 500010 PAL
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