Elesta S P A

FDA Filings

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

FDA Registration(s)

• Registration Number: 3015077548
• FEI Number: 3015077548
• Name: Michael van der Woude
• Owner & Operator: Elesta SPA
• Contact Address: Via Baldanzese 17 ; Calenzano IT-FI Firenze 50041 IT
• Official Correspondent:
  • Valentina Gonnelli
  • 39-055-8826807-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road, Building 1 Suite 300 ; Austin, TX 78746 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 08052286590227 ELESTA SPA	Laser Thermal Therapy Kit L E	2023-11-14
GUDID 08052286590210 ELESTA SPA	Laser Thermal Therapy Kit S E	2023-11-14
GUDID 08052286590173 ELESTA SPA	Echolaser Smart Interface (ESI)	2021-06-28
GUDID 08052286590166 ELESTA SPA	INTRODUCER	2021-06-28
GUDID 08052286590159 ELESTA SPA	INTRODUCER	2021-06-28
OUG Michael van der Woude [Elesta SPA]	Echolaser Smart Interface (ESI)	2019-06-07