Rontis Hellas S A

FDA Filings

This page includes the latest FDA filings for Rontis Hellas S 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: 3011142981
• FEI Number: 3011142981
• Name: Rontis Hellas S.A.
• Owner & Operator: Rontis Hellas SA
• Contact Address: Industrial Area of Larissa ; Larissa GR-V Thessalia 40006 GR
• Official Correspondent:
  • Elena Panorgia
  • 30-241-0541489-x
• US Agent:
  • Jessica Oswald-McLeod
  • Nipro Medical Corporation
  • 305 5997174
  • jessicao@nipromed.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Industrial Area of Larisa ; Larisa Larisa, 41500 GR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K190037 | LIT Rontis Hellas S.A. [Rontis Hellas SA]	Cronus HP ? High Pressure Peripheral balloon catheter	2019-11-06
PMN K190037 | DQY Rontis Hellas S.A. [Rontis Hellas SA]	Cronus HP ? High Pressure Peripheral balloon catheter	2019-11-06