Horentek S R L

FDA Filings

This page includes the latest FDA filings for Horentek S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014055340
FEI Number3014055340
NameHORENTEK S.R.L.
Owner & OperatorHorentek S.r.l.
Contact AddressVia Aurelio Nicolodi 43/5
Livorno IT-LI Livorno 57121 IT
US Agent
Importing Logistics Registration
ImporterHorentek Hearing Diagnostics
Address732 W. Blvd 102
Hurst, TX 76053 UNITED STATES
Importing Logistics Registration
ImporterHorentek Hearing Diagnostics LLC
Address2408 W Walnut
Garland, TX 75040 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressVia Aurelio Nicolodi 43/5
Livorno Livorno, 57121 IT
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
HORENTEK S.R.L.
Hore2017-10-20
HORENTEK S.R.L.
Mito2017-10-20
HORENTEK S.R.L.
Mini Mito2017-10-20
HORENTEK S.R.L.
App2017-10-20

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