Shl Telemedicine I N T L T D

FDA Filings

This page includes the latest FDA filings for Shl Telemedicine I N T 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 Number: 3003647588
• FEI Number: 3003647588
• Name: Tova Rivnay
• Owner & Operator: SHL TeleMedicine International Ltd
• Contact Address: 90 Yigal Alon street ; Tel Aviv IL-NOTA 67891 IL
• Official Correspondent:
  • Yoram Levy
  • 972-4-6388837-x
• US Agent:
  • Tova Rivnay
  • Qsite
  • 512 5354930
  • 512 5356103
  • yoram@qsitemed.com
• Importing Logistics Registration:
  • Importer: SHL Telemedicine USA, Inc.
  • Address: 260 Madison Ave 2FL ; Manhattan, NY 10016 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 77 Dorcar Rd ; Newton, MA 02459 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07290008960427 SHL TELEMEDICINE INTERNATIONAL LTD.	CARDIO MONITOR CENTER VISION	2023-08-30
GUDID 07290008960267 SHL TELEMEDICINE INTERNATIONAL LTD.	RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER	2023-08-30
GUDID 07290008960250 SHL TELEMEDICINE INTERNATIONAL LTD.	CardioSen'C	2023-08-29
GUDID 07290008960359 SHL TELEMEDICINE INTERNATIONAL LTD.	smartheart	2019-02-06
OUG Tova Rivnay [SHL TeleMedicine International Ltd]	CCM and Receiving Software	2013-04-18
PMN K113514 | DXH Tova Rivnay [SHL TeleMedicine International Ltd]	Smartheart	2012-03-26
PMN K113514 | DXH Tova Rivnay [SHL TeleMedicine International Ltd]	Smartheart Pro	2012-03-26
PMN K113514 SHL TELEMEDICINE INTERNATIONAL LTD.	SMARTHEART	2012-02-22
PMN K080047 | DXH Tova Rivnay [SHL TeleMedicine International Ltd]	CardioSenC	2008-08-13
PMN K080047 SHL TELEMEDICINE INTERNATIONAL LTD.	CARDIOSEN'C	2008-07-11
PMN K981807 | DPS Tova Rivnay [SHL TeleMedicine International Ltd]	MODEL S-CV5-96	2008-03-30
PMN K981807 | DPS Tova Rivnay [SHL TeleMedicine International Ltd]	CARDIOVISION SOFTWARE,	2008-03-30
PMN K003392 | DPS Tova Rivnay [SHL TeleMedicine International Ltd]	MODEL S-CV7-00	2008-03-30
PMN K003392 | DPS Tova Rivnay [SHL TeleMedicine International Ltd]	CARDIO MONITOR CENTER VISION	2008-03-30
PMN K063609 | DXH Tova Rivnay [SHL TeleMedicine International Ltd]	Cardio'R	2007-11-27
PMN K063609 SHL TELEMEDICINE INTERNATIONAL LTD.	RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER	2007-09-12
PMN K003392 SHL TELEMEDICINE INTERNATIONAL LTD.	CARDIO MONITOR CENTER VISION; MODEL S-CV7-00	2001-01-25
PMN K981807 SHL TELEMEDICINE INTERNATIONAL LTD.	CARDIOVISION SOFTWARE, MODEL S-CV5-96	1998-08-19