Manatec

FDA Filings

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

FDA Registration(s)

• Registration Number: 1000610255
• FEI Number: 1000610255
• Name: MANATEC
• Owner & Operator: Manatec SARL
• Contact Address: 21 rue du Stade ; Petit Ebersviller FR-NOTA 57730 FR
• Official Correspondent:
  • Benoit Bosquet
  • 33-372-825000-x
• US Agent:
  • Peter O Loughlin
  • Graphic Controls Acquisition Corp d/b/a Vermed
  • 800 6696905
  • 888 6584941
  • poloughlin@vermed.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10 bis Rue Jacob Courant ; Poissy Ile-de-France, 78300 FR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K140102 | DSB MANATEC [Manatec SARL]	PhysioFlow Q-Link	2014-06-27
PMN K140102 | DSB MANATEC [Manatec SARL]	PF07 Q-Link	2014-06-27
PMN K103283 | DSB MANATEC [Manatec SARL]	PhysioFlow Enduro	2012-04-06
PMN K103283 | DSB MANATEC [Manatec SARL]	PF07 Enduro	2012-04-06
PMN K060387 | DSB MANATEC [Manatec SARL]	PhysioFlow System	2009-01-30