Mandelay Kft

FDA Filings

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

FDA Registration(s)
Registration Number3010452718
FEI Number3010452718
NameMANDELAY KFT
Owner & OperatorMandelay Kft
Contact AddressGyartelep HRSZ 12001/33
Szigetszentmiklos HU-PE Pest 2310 HU
Official Correspondent
  • Ibolya Bodzsar
  • 36-20-5587716-x
US Agent
Importing Logistics Registration
ImporterSMARTRONICS LLC
Address410 W 5th St
Pinconning, MI 48650 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressGyartelep HRSZ 12001/33
Szigetszentmiklos Pest, 2310 HU
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
MANDELAY KFT
SCIO2013-07-31
MANDELAY KFT
QUEST 92013-07-31

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