Tova Rivnay

FDA Filings

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

FDA Registration(s)
Registration Number3003647588
FEI Number3003647588
NameTova Rivnay
Owner & OperatorSHL TeleMedicine International Ltd
Contact Address90 Yigal Alon street
Tel Aviv IL-NOTA 67891 IL
Official Correspondent
  • Yoram Levy
  • 972-4-6388837-x
US Agent
Importing Logistics Registration
ImporterSHL Telemedicine USA, Inc.
Address260 Madison Ave 2FL
Manhattan, NY 10016 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address77 Dorcar Rd
Newton, MA 02459 US
Establishment TypeManufacture Medical Device

Registration Number3008085016
FEI Number3008085016
NameTova Rivnay
Owner & OperatorEndymed Medical Ltd
Contact Address12 Leshem Street North Industrial Park
Caesarea IL-Z Ha Zafon 3088900 IL
Official Correspondent
  • Yoram Levy
  • 972-4-6388837-x
US Agent
Importing Logistics Registration
ImporterEndyMed Medical Inc
Address790 Madison Avenue Suite 402
New York, NY 10065 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address77 Dorcar Rd
Newton, MA 02459 US
Establishment TypeManufacture Medical Device

Registration Number3013214485
FEI Number3013214485
NameTova Rivnay
Owner & OperatorZetiq Technologies Ltd.
Contact AddressKyriat Atidim, Building 7
Tel Aviv IL-TA Tel-Aviv 6158101 IL
Official Correspondent
  • Ouriel Faktor
  • 972-73-2753450-x
US Agent
Importing Logistics Registration
ImporterPrescient Pharma LLC
Address580 Washington Street
Canton, MA 02021 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address77 Dorcar Rd.
Newton, MA 02459 US
Establishment TypeManufacture Medical Device

Registration Number3008753275
FEI Number3008753275
NameTova Rivnay
Owner & OperatorPollogen Ltd.
Contact Address6 Kaufman Str.
Tel Aviv IL-TA Tel-Aviv 6801298 IL
Official Correspondent
  • Ayala Kamil
  • 972-3-5104110-158
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address77 Dorcar Rd
Newton, MA 02459 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

Registration Number3010363430
FEI Number3010363430
NameTova Rivnay
Owner & OperatorHealthWatch
Contact Address23 Hataas Street
Kfar Saba IL-M HaMerkaz 4442500 IL
Official Correspondent
  • Yoram Levy
  • 972-77-5434541-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address77 Dorcar Rd
Newton, MA 02459 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Tova Rivnay [Pollogen Ltd.]
STOP X, Model: STOP U2019-08-21
Tova Rivnay [Pollogen Ltd.]
STOP U2019-08-21
Tova Rivnay [Endymed Medical Ltd]
Contour Handpiece2018-11-26
Tova Rivnay [Pollogen Ltd.]
Pollogen Legend+ System2018-08-28
Tova Rivnay [Pollogen Ltd.]
Legend Pro2018-08-28
Tova Rivnay [Pollogen Ltd.]
Stop U2017-12-28
Tova Rivnay [Pollogen Ltd.]
Pollogen Legend+ System2017-12-21
Tova Rivnay [Zetiq Technologies Ltd.]
CellDetect? Staining Kit2017-04-27
Tova Rivnay [Endymed Medical Ltd]
EndyGel2017-02-08
Tova Rivnay [Endymed Medical Ltd]
Over the Counter Newa Skin Therapy System2016-11-23
Tova Rivnay [Endymed Medical Ltd]
Newa2016-11-23
Tova Rivnay [Endymed Medical Ltd]
Newa Plus2016-11-23
Tova Rivnay [HealthWatch]
Master Caution Device2015-03-10
Tova Rivnay [HealthWatch]
MCD2015-03-10
Tova Rivnay [HealthWatch]
MCC2014-11-27
Tova Rivnay [Endymed Medical Ltd]
Intensif2014-03-19
Tova Rivnay [Endymed Medical Ltd]
Ilooda Secret2014-03-19
Tova Rivnay [Endymed Medical Ltd]
Intensif2014-03-19
Tova Rivnay [Endymed Medical Ltd]
Ilooda Secret2014-03-19
Tova Rivnay [Endymed Medical Ltd]
EndyMed Newa2013-12-24
Tova Rivnay [Pollogen Ltd.]
geneO+ U2013-11-05
Tova Rivnay [SHL TeleMedicine International Ltd]
CCM and Receiving Software2013-04-18
Tova Rivnay [HealthWatch]
Master Caution Garment2013-02-17
Tova Rivnay [Endymed Medical Ltd]
MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM2012-11-02
Tova Rivnay [Endymed Medical Ltd]
CLEAR100 PHOTOTHERAPY SYSTEM2012-11-02
Tova Rivnay [Endymed Medical Ltd]
CLEAR100 PHOTOTHERAPY SYSTEM2012-11-02
Tova Rivnay [Endymed Medical Ltd]
RECLEAR PHOTOTHERAPY SYSTEM2012-11-02
Tova Rivnay [Endymed Medical Ltd]
RECLEAR PHOTOTHERAPY SYSTEM2012-11-02
Tova Rivnay [Endymed Medical Ltd]
MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM2012-11-02
Tova Rivnay [Endymed Medical Ltd]
ICLEAR PHOTOTHERAPY SYSTEM2012-11-02
Tova Rivnay [Endymed Medical Ltd]
CLEARLIGHT PHOTOTHERAPHY SYSTEM2012-11-02
Tova Rivnay [Endymed Medical Ltd]
iFine2012-06-16
Tova Rivnay [Endymed Medical Ltd]
Pure by EndyMed2012-06-16
Tova Rivnay [Endymed Medical Ltd]
Glow by EndyMed2012-06-16
Tova Rivnay [Endymed Medical Ltd]
Eclipse Firma2012-06-16
Tova Rivnay [Endymed Medical Ltd]
iFine2012-06-16
Tova Rivnay [Endymed Medical Ltd]
Pure by EndyMed2012-06-16
Tova Rivnay [Endymed Medical Ltd]
Glow by EndyMed2012-06-16
Tova Rivnay [Endymed Medical Ltd]
Eclipse Firma2012-06-16
Tova Rivnay [SHL TeleMedicine International Ltd]
Smartheart2012-03-26
Tova Rivnay [SHL TeleMedicine International Ltd]
Smartheart Pro2012-03-26
Tova Rivnay [Endymed Medical Ltd]
Fractional Skin Resurfacing (FSR)2011-05-15
Tova Rivnay [Endymed Medical Ltd]
iFine2009-12-04
Tova Rivnay [Endymed Medical Ltd]
Shaper3D2009-12-04
Tova Rivnay [Endymed Medical Ltd]
Endymed Pro Skin Treatment System2009-12-04
Tova Rivnay [SHL TeleMedicine International Ltd]
CardioSenC2008-08-13
Tova Rivnay [SHL TeleMedicine International Ltd]
MODEL S-CV5-962008-03-30
Tova Rivnay [SHL TeleMedicine International Ltd]
CARDIOVISION SOFTWARE,2008-03-30
Tova Rivnay [SHL TeleMedicine International Ltd]
MODEL S-CV7-002008-03-30
Tova Rivnay [SHL TeleMedicine International Ltd]
CARDIO MONITOR CENTER VISION2008-03-30
Tova Rivnay [SHL TeleMedicine International Ltd]
Cardio'R2007-11-27

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