Eight Medical I N T B V

FDA Filings

This page includes the latest FDA filings for Eight Medical I N T B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011831824
• FEI Number: 3011831824
• Name: EIGHT MEDICAL INTERNATIONAL B.V.
• Owner & Operator: Eight Medical International B.V.
• Contact Address: Gardermoenbaan 25 ; Rotterdam NL-NOTA 3045AX NL
• Official Correspondent:
  • Marie Carpenter
  • 31-85-8771680-x
• US Agent:
  • Marie Carpenter
  • Eight Medical Corporation
  • 812 8220404
  • carpenter.marie@eightmedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Gardermoenbaan 25 ; Rotterdam Zuid-Holland, 3045AX NL
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 08719992086016 Eight Medical International B.V.	Lavage Procedure Kit	2020-04-20
GUDID 08719992086009 Eight Medical International B.V.	Recirculator	2020-04-20
PMN K102900 | LGZ EIGHT MEDICAL INTERNATIONAL B.V.	Recirculator 8.0	2017-08-31