Urosystem Kft

FDA Filings

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

FDA Registration(s)
Registration Number3016447772
FEI Number3016447772
NameGabor Kalman
Owner & OperatorUrosystem Kft
Contact AddressSzent Istvan krt 18
Budapest HU-BU Budapest 1137 HU
Official Correspondent
  • Gabor K Kalman
  • 36-20-9345347-x
US Agent
Importing Logistics Registration
ImporterUrosystem North America Inc
117371649
Address575 Madison Ave, 10th floor
New York, NY 10022 UNITED STATES
Email Addressgabor.kalman@urosystem.com
Phone1 212 6050225
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address575 Madison Ave, 10th floor
New York City, NY 10022 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Gabor Kalman [Urosystem Kft]
UroDapter2020-01-10

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