Earlysense L T D

FDA Filings

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

FDA Registration(s)
Registration Number3008693420
FEI Number3008693420
NameEARLYSENSE LTD
Owner & OperatorEarlySense Ltd.
Contact Address7 Derech Zeev Jabotinsky
RamatGan IL-TA Tel-Aviv 5252007 IL
Official Correspondent
  • Dalia Argaman
  • 972-3-7522330-106
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7 Derech Zeev Jabotinsky
RamatGan HaMerkaz, 5252007 IL
Establishment TypeManufacture Medical Device



Registration Number3009161340
FEI Number3009161340
NameEarlySense Inc.
Owner & OperatorEarlySense Ltd.
Contact Address7 Derech Zeev Jabotinsky
RamatGan IL-TA Tel-Aviv 5252007 IL
Official Correspondent
  • Dalia Argaman
  • 972-3-7522330-106
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address800 West Cummings Park, Suite 6400 Woburn, MA 01801
Woburn, MA 01801 US



FDA Filings

Device
Company
DeviceDate
EARLYSENSE LTD
EarlySense® InSight™ AME-020212021-07-15
EARLYSENSE LTD
EarlySense® InSight™ AME-01340-02 US2020-02-06
EARLYSENSE LTD
EarlySense® Bedside Unit AME-00900 US2020-02-06
EARLYSENSE LTD
EarlySense® BEX Sensor 2018-08-29
EARLYSENSE LTD
Hill-Rom® Heart and Respiration Rate Monitoring Sy Hill-Rom PN 2008982018-08-29
EARLYSENSE LTD
EarlySense® Contact-Free Sensor AME-00200 US2018-07-06
EARLYSENSE LTD
EarlySense® Central Display Unit AME-002500 US2018-07-06
EARLYSENSE LTD
EarlySense® Chair Sensor AME-00271 US2018-07-06
EARLYSENSE LTD [EarlySense Ltd.]
EarlySense Bed Sensing Unit2018-01-21
EarlySense Ltd.
EarlySense Bed Sensing Unit2018-01-04
EARLYSENSE LTD [EarlySense Ltd.]
EarlySense Percept2017-09-26
EARLYSENSE LTD [EarlySense Ltd.]
Earlysense Insight2016-07-10
EarlySense Ltd.
EarlySense Insight Sytem2016-05-06
EARLYSENSE LTD [EarlySense Ltd.]
EarlySense Central Display Station (CDS)2015-10-14
EARLYSENSE LTD [EarlySense Ltd.]
EarlySense Central Display Station (CDS)2015-10-14
EARLYSENSE LTD.
EarlySense Central Display Station (CDS)2015-08-31
EARLYSENSE LTD [EarlySense Ltd.]
EarlySense Chair Sensing Unit2014-06-26
EARLYSENSE LTD [EarlySense Ltd.]
EarlySense Chair Sensing Unit2014-06-26
EARLYSENSE LTD [EarlySense Ltd.]
EarlySense 2.02014-06-26
EARLYSENSE LTD.
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM2014-06-13
EARLYSENSE LTD.
EARLYSENSE2013-12-18
EARLYSENSE LTD [EarlySense Ltd.]
Patient Care Manager (PCM)2012-10-29
EARLYSENSE LTD [EarlySense Ltd.]
Central Display Station2012-10-29
EARLYSENSE LTD [EarlySense Ltd.]
CDS2012-10-29
EARLYSENSE LTD [EarlySense Ltd.]
EverOn2012-10-29
EARLYSENSE LTD [EarlySense Ltd.]
EarlySense2012-10-29
EARLYSENSE LTD.
EARLYSENSE CENTRAL DISPLAY SYSTEM2012-09-10
EARLYSENSE LTD.
EARLYSENSE (EVERON) SYSTEM2012-06-08
EARLYSENSE LTD.
EVERON CENTRAL DISPLAY STATION (CDS)2011-04-19
EARLYSENSE LTD.
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.02010-08-06
EARLYSENSE LTD.
EVERON 1.02010-05-24
EARLYSENSE LTD.
EVERON2009-03-25
EARLYSENSE LTD.
EARLYSENSE ES-16 SYSTEM2007-11-15

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091632368Haifa,Israel -> New York/Newark Area, Newark, New JerseyEARLYSENSE SENSOR ASSEMBLY3 SKD
2020072213824Haifa,Israel -> New York/Newark Area, Newark, New JerseyEARLYSENSE SENSOR PACKED US .2 SKD
2020070632252Haifa,Israel -> New York/Newark Area, Newark, New JerseyEARLYSENSE SENSOR PACKED US .2 SKD
2020061557459Haifa,Israel -> New York/Newark Area, Newark, New JerseySTC2 SKIDS WITH EARLYSENSE SENSOR PACKED US . .2 SKD
2020061557503Haifa,Israel -> New York/Newark Area, Newark, New JerseySTC5 SKIDS OF EARLYSENSE SENSOR ASSEMBLY HS . . .5 SKD
2020032422423Haifa,Israel -> New York/Newark Area, Newark, New JerseyEARLYSENSE SENSOR PACKED US .4 SKD
2020031641664Haifa,Israel -> New York/Newark Area, Newark, New JerseySTC3 PALLETS OF EARLYSENSE SENSOR ASSEMBLY H .3 SKD
2020022446071Haifa,Israel -> New York/Newark Area, Newark, New JerseyEARLYSENSE SENSOR PACKED US HS 9018.90.5080 .4 SKD

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