Cefimeca

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006563559
• FEI Number: 3006563559
• Name: Rene van de Zande
• Owner & Operator: Cefimeca
• Contact Address: 15 rue de la Chazotte ; La Talaudiere FR-42 Loire 42350 FR
• Official Correspondent:
  • Frederic Mazenod
  • 33-047-7531919-x
• 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, Ste 300 ; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K120262 | HSX Rene van de Zande [Cefimeca]	U-Knee Tec	2018-12-28
PMN K120262 | HSX Rene van de Zande [Cefimeca]	Knee Tec PFJ	2018-12-28
PMN K111970 | KRR Rene van de Zande [Cefimeca]	Knee Tec PFJ	2018-12-28