Sonele Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3011162972
• FEI Number: 3011162972
• Name: Rene van de Zande
• Owner & Operator: SONELE Inc.
• Contact Address: 46 Riviera Drive ; Markham CA-ON Ontario L3R 5M1 CA
• Official Correspondent:
  • Eric Reider
  • 1-905-7528886-6014
• US Agent:
  • Rene van de Zande
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • usagent@emergogroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K173810 | IYN Rene van de Zande [SONELE Inc.]	Ventripoint Medical System Plus (VMS+)	2018-06-06
PMN K180636 | OIJ Rene van de Zande [SONELE Inc.]	ExactVu? High Resolution Micro-Ultrasound System	2018-05-24
PMN K180636 | IYO Rene van de Zande [SONELE Inc.]	ExactVu? High Resolution Micro-Ultrasound System	2018-05-24
PMN K180636 | ITX Rene van de Zande [SONELE Inc.]	ExactVu? High Resolution Micro-Ultrasound System	2018-05-24